title: Weight Loss, Glycemic Control, and Cardiovascular Disease Risk Factors in Response to Differential Diet Composition in a Weight Loss Program in Type 2 Diabetes: A Randomized Controlled Trial In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss The Effects of Low-Carbohydrate versus Conventional Weight Loss Diets in Severely Obese Adults: One-Year Follow-up of a Randomized Trial Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study Adherence to a Mediterranean diet and survival in a Greek population. 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EVALUATION OF THE EFFECTIVENESS OF A LOW SODIUM DIET IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION A High-Protein Diet With Resistance Exercise Training Improves Weight Loss and Body Composition in Overweight and Obese Patients With Type 2 Diabetes A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. Assessment of quality of life in a randomized clinical trial of candesartan only or in combination with DASH diet for hypertensive patients. 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One-year weight maintenance after significant weight loss in healthy overweight and obese subjects: does diet composition matter? A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Australian National Health and Medical Research Council dietary salt study in mild hypertension. Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. The Trials of Hypertension Prevention Collaborative Research Group. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Feasibility of a long-term low-sodium diet in mild hypertension. Effect of energy restriction, weight loss, and diet composition on plasma lipids and glucose in patients with type 2 diabetes. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. Short-term effects of severe dietary carbohydrate-restriction advice in Type 2 diabetes--a randomized controlled trial. Vegetable protein and fiber from cereal are inversely associated with the risk of hypertension in a Spanish cohort. Long-term effects of a Palaeolithic-type diet in obese postmenopausal women: a 2-year randomized trial Effects of a low-salt diet and of acute salt loading on blood pressure and intralymphocytic sodium concentration in young subjects with borderline hypertension. Beta blockade, diuretics, and salt restriction for the management of mild hypertension: a randomised double blind trial. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. 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abstract: OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P < 0.001 intervention effect ) . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P < 0.001 ) . The lower versus higher carbohydrate groups maintained lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet  tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( < 40 mg/dL ) for men or less than 1.30 mmol/L ( < 50 mg/dL ) for women , blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active smoking , and sleep apnea ( 12 ) . All variables were assessed for normality before entry into the analyses . Triglyceride , insulin , and glucose levels were skewed and thus were log-transformed before the analyses . Baseline differences between diet groups were compared by chi-square analysis for dichotomous variables and by the unpaired t-test for continuous variables . All P values are 2-sided , and a P value of 0.05 was considered statistically significant . Analyses were performed with SPSS statistical software , version 11.1 ( SPSS , Inc. , Chicago , Illinois ) . Missing Data Of the 132 enrolled persons , follow-up was done at 6 months for 79 persons and at 1 year for 87 persons . For measurements at 6 months , we retrieved weights on an additional 16 persons on the low-carbohydrate diet and 23 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 6.6 1.2 months ) . For measurements at 1 year , we retrieved weights on 18 persons on the low-carbohydrate diet and 21 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 13.5 3.2 months ) . Thus , we had 6-month weights on 118 of 132 persons ( 89 % ) and 1-year weights on 126 of 132 persons ( 96 % ) . Of the 18 persons who missed the 6-month visit but returned for the 1-year visit ( 6 in the low-carbohydrate group and 12 in the conventional diet group ) , all but 2 had 6-month weights retrieved from medical records . Of the 6 persons for whom no 1-year weights were available , 2 were in the low-carbohydrate group and 4 in the conventional diet group . The weights retrieved from medical records were obtained on scales that were different from those used for the study and were probably obtained in a nonuniform manner with regard to clothing . We used several approaches to h and le the 45 participants with missing data for diet recall and metabolic measurements . For the primary analysis by r and om-coefficient analysis , we assumed data were missing at r and om . To verify this assumption , we performed sensitivity analyses based on comparisons of baseline characteristics and weight loss differences between those who dropped out and those who completed the study . We also performed 2 additional sensitivity Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin  in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240 BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line .  Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality OBJECTIVE —The purpose of this study was to compare the effects of high – monounsaturated fatty acid ( MUFA ) and high-carbohydrate ( CHO ) diets on body weight and glycemic control in men and women with type 2 diabetes . RESEARCH DESIGN AND METHODS —Overweight/obese participants with type 2 diabetes ( n = 124 , age = 56.5 ± 0.8 years , BMI = 35.9 ± 0.3 kg/m2 , and A1C = 7.3 ± 0.1 % ) were r and omly assigned to 1 year of a high-MUFA or high-CHO diet . Anthropometric and metabolic parameters were assessed at baseline and after 4 , 8 , and 12 months of dieting . RESULTS —Baseline characteristics were similar between the treatment groups . The overall retention rate for 1 year was 77 % ( 69 % for the high-MUFA group and 84 % for the high-CHO group ; P = 0.06 ) . Based on food records , both groups had similar energy intake but a significant difference in MUFA intake . Both groups had similar weight loss over 1 year ( −4.0 ± 0.8 vs. −3.8 ± 0.6 kg ) and comparable improvement in body fat , waist circumference , diastolic blood pressure , HDL cholesterol , A1C , and fasting glucose and insulin . There were no differences in these parameters between the groups . A follow-up assessment of a subset of participants ( n = 36 ) was conducted 18 months after completion of the 52-week diet . These participants maintained their weight loss and A1C during the follow-up period . CONCLUSIONS —In individuals with type 2 diabetes  , high-MUFA diets are an alternative to conventional lower-fat , high-CHO diets with comparable beneficial effects on body weight , body composition , cardiovascular risk factors , and glycemic control Aims /hypothesisTo compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss , using group-based interventions , among overweight people with type 2 diabetes . Study design Multicentre parallel ( 1:1 ) design , blinded r and omised controlled trial . Methods Individuals with type 2 diabetes aged 30–75 years and a BMI > 27 kg/m2 were r and omised , by an independent statistician using sequentially numbered sealed envelopes , to be prescribed either a low-fat high-protein ( 30 % of energy as protein , 40 % as carbohydrate , 30 % as fat ) or a low-fat high-carbohydrate ( 15 % of energy as protein , 55 % as carbohydrate , 30 % as fat ) diet . Participants attended 18 group sessions over 12 months . Primary outcomes were change in weight and waist circumference assessed at baseline , 6 and 12 months . Secondary outcomes were body fatness , glycaemic control , lipid profile , blood pressure and renal function . A further assessment was undertaken 12 months after the intervention . Research assessors remained blinded to group allocation throughout . Intention-to-treat analysis was performed . Results A total of 419 participants were enrolled ( mean ± SD age 58 ± 9.5 years , BMI 36.6 ± 6.5 kg/m2 and HbA1c 8.1 ± 1.2 % ( 65 mmol/mol ) ) . The study was completed by 70 % ( 294/419 ) . No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up . Both groups had lost weight ( 2–3 kg , p < 0.001 ) and reduced their waist circumference ( 2–3 cm , p < 0.001 ) by 12 months and largely maintained this weight loss for the following 12 months . By 6 months , the difference in self-reported dietary protein between groups was small ( 1.1 % total energy ; p < 0.001 ) . No significant differences between groups were found in secondary outcomes : body fatness , HbA1c , lipids , blood pressure and renal function . There were no important adverse effects . Conclusions /interpretationIn a ‘ real-world ’ setting , prescription of an energy-reduced low-fat diet , with either increased protein or carbohydrate , results in similar modest losses in weight and waist circumference over 2 years . Trial registration : Australia New Zeal and Clinical Trials Register ACTRN12606000490572 Funding : The Health Research Council of New Zeal and ( 06/337 ) Background We lack a comprehensive assessment of the risks and benefits of calorie restriction in older adults at high risk for cardiometabolic disease . Calorie restriction may reduce visceral adipose tissue ( VAT ) but also have negative effects on lean mass and quality of life . Methods We conducted a 52-week , r and omized controlled trial involving 164 older adults with obesity taking at least one medication for hyperlipidemia , hypertension , or diabetes . Interventions included an exercise intervention alone ( Exercise ) , or with diet modification and body weight maintenance ( Maintenance ) , or with diet modification and energy restriction ( Weight Loss ) . The primary outcome was change in VAT at 12 months . Secondary outcomes included cardiometabolic risk factors , functional status , and quality of life . Results A total of 148 participants had measured weight at 12 months . Despite loss of -1.6 % ± 0.3 % body fat and 4.1 % ± 0.7 % initial body weight , Weight Loss did not have statistically greater loss of VAT ( -192.6 ± 185.2 cm3 ) or lean mass ( -0.4 ± 0.3 kg ) compared with Exercise ( VAT = -21.9 ± 173.7 cm3 ; lean mass = 0.3 ± 0.3 kg ) . Quality of life improved in all groups with no differences between groups . No significant changes in physical function were observed . Weight Loss had significantly greater improvements in blood glucose ( -8.3 ± 3.6 mg/dL , p < .05 ) and HDL-cholesterol ( 5.3 ± 1.9 , p < .01 ) compared with Exercise . There were no group differences in the frequency of adverse events . Conclusions While moderate calorie restriction did not significantly decrease VAT in older adults at high risk for cardiometabolic disease , it did reduce total body fat and cardiometabolic risk factors without significantly more adverse events and lean mass loss BACKGROUND Weight loss reduces blood pressure , and the Dietary Approaches to Stop Hypertension ( DASH ) diet has also been shown to lower blood pressure . OBJECTIVE Our goal was to assess the effect on blood pressure of 2 weight-reduction diets : a low-fat diet ( LF diet ) and a moderate-sodium , high-potassium , high-calcium , low-fat DASH diet ( WELL diet ) . DESIGN After baseline measurements , 63 men were r and omly assigned to either the WELL or the LF diet for 12 wk , and both diet groups undertook 0.5 h of moderate physical activity on most days of the week . RESULTS Fifty-four men completed the study . Their mean ( + /-SD ) age was 47.9 + /- 9.3 y ( WELL diet  , n = 27 ; LF diet , n = 27 ) , and their mean baseline home systolic and diastolic blood pressures were 129.4 + /- 11.3 and 80.6 + /- 8.6 mm Hg , respectively . Body weight decreased by 4.9 + /- 0.6 kg ( + /-SEM ) in the WELL group and by 4.6 + /- 0.6 kg in the LF group ( P < 0.001 for both ) . There was a greater decrease in blood pressure in the WELL group than in the LF group [ between-group difference ( week 12 -baseline ) in both SBP ( 5.5 + /- 1.9 mm Hg ; P = 0.006 ) and DBP ( 4.4 + /- 1.2 mm Hg ; P = 0.001 ) ] . CONCLUSIONS For a comparable 5-kg weight loss , a diet high in low-fat dairy products , vegetables , and fruit ( the WELL diet ) result ed in a greater decrease in blood pressure than did the LF diet . This dietary approach to achieving weight reduction may confer an additional benefit in reducing blood pressure in those who are overweight Studies in women with type 2 diabetes demonstrated adverse effects on body fat distribution of a low-fat diet relative to a high monounsaturated fat diet . We performed a r and omized 12-wk parallel design study of two 6000-kJ diets : 35 % energy from fat ( high monounsaturated fat diet , HIMO ) , or 12 % energy from fat ( very low-fat diet , VLF ) to determine whether this also occurred in nondiabetic women .  Body fat distribution , fasting plasma glucose , blood pressure , and fasting serum lipids were measured at wk 0 and 12 in 62 women ( BMI > 27 kg/m(2 ) ) .  Weight loss ( 9.5 + /- 2.4 vs. 9.4 + /- 3.4 kg , VLF vs. HIMO ) and total fat loss ( 6.1 + /- 2.4 vs. 6.3 + /- 2.7 kg , VLF vs. HIMO ) did not differ in the groups . There was a diet x menopausal status interaction in lean mass changes ( P = 0.005 ) such that in premenopausal women , HIMO produced a lower loss of lean mass than the low-fat diet ( 0.4 + /- 2.3 vs. 2.9 + /- 2.7 kg , P = 0.006 ) with the opposite but nonsignificant effect seen in postmenopausal women . There was a greater decrease in total plasma cholesterol in women who consumed VLF compared with those who consumed HIMO ( 0.82 + /- 0.0.51 vs. 0.50 + /- 0.48 mmol/L , P < 0.001 for time , P < 0.05 for diet effect ) . This was also true for the change in HDL cholesterol ( 0.18 + /- 0.23 vs. 0.04 + /- 0.19 mmol/L , VLF and HIMO , respectively , P < 0.001 for time , P < 0.05 for diet effect ) . The LDL/HDL ratio was reduced in both groups with no effect of diet ( 0.16 + /- 0.51 vs. 0.16 + /- 0.45 , VLF and HIMO , respectively , P < 0.05 ) . In conclusion , weight , total fat mass , and regional fat mass loss did not differ in the 2 groups of women but there was an apparent preservation of lean mass in premenopausal women consuming HIMO BACKGROUND Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on  type 2 diabetes ( T2D ) . OBJECTIVE We compared the effects of a very-low-carbohydrate , high-unsaturated fat , low-saturated fat ( LC ) diet with a high-carbohydrate , low-fat ( HC ) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk . DESIGN In this r and omized controlled trial that was conducted in an outpatient research clinic , 115 obese adults with T2D [ mean ± SD age : 58 ± 7 y ; body mass index ( in kg/m(2 ) ) : 34.6 ± 4.3 ; glycated hemoglobin ( HbA1c ) : 7.3 ± 1.1 % ; duration of diabetes : 8 ± 6 y ] were r and omly assigned to consume either a hypocaloric LC diet [ 14 % of energy as carbohydrate ( carbohydrate < 50 g/d ) , 28 % of energy as protein , and 58 % of energy as fat ( < 10 % saturated fat ) ] or an energy-matched HC diet [ 53 % of energy as carbohydrate , 17 % of energy as protein , and 30 % of energy as fat ( < 10 % saturated fat ) ] combined with supervised aerobic and resistance exercise ( 60 min ; 3 d/wk ) . Outcomes were glycemic control assessed with use of measurements of HbA1c , fasting blood glucose , glycemic variability assessed with use of 48-h continuous glucose monitoring , diabetes medication , weight , blood pressure , and lipids assessed at baseline , 24 , and 52 wk . RESULTS Both groups achieved similar completion rates ( LC diet : 71 % ; HC diet : 65 % ) and mean ( 95 % CI ) reductions in weight [ LC diet : -9.8 kg ( -11.7 , -7.9 kg ) ; HC diet : -10.1 kg ( -12.0 , -8.2 kg ) ] , blood pressure [ LC diet : -7.1 ( -10.6 , -3.7)/-6.2 ( -8.2 , -4.1 ) mm Hg ; HC diet : -5.8 ( -9.4 , -2.2)/-6.4 ( -8.4 , -4.3 ) mm Hg ] , HbA1c [ LC diet : -1.0 % ( -1.2 % , -0.7 % ) ; HC diet : -1.0 % ( -1.3 % , -0.8 % ) ] , fasting glucose [ LC diet : -0.7 mmol/L ( -1.3 , -0.1 mmol/L ) ; HC diet : -1.5 mmol/L ( -2.1 , -0.8 mmol/L ) ] , and LDL cholesterol [ LC diet : -0.1 mmol/L ( -0.3 , 0.1 mmol/L ) ; HC diet : -0.2 mmol/L ( -0.4 , 0.03 mmol/L ) ] ( P-diet effect ≥ 0.10 ) . Compared with the HC-diet group , the LC-diet group achieved greater mean ( 95 % CI ) reductions in the diabetes medication score [ LC diet : -0.5 arbitrary units ( -0.7 , -0.4 arbitrary units ) ; HC diet : -0.2 arbitrary units ( -0.4 , -0.06 arbitrary units ) ; P = 0.02 ] , glycemic variability assessed by measuring the continuous overall net glycemic action-1 [ LC diet : -0.5 mmol/L ( -0.6 , -0.3 mmol/L ) ; HC diet : -0.05 mmol/L ( -0.2 , -0.1 mmol/L ) ; P = 0.003 ] , and triglycerides [ LC diet : -0.4 mmol/L ( -0.5 , -0.2 mmol/L ) ; HC diet : -0.01 mmol/L ( -0.2 , 0.2 mmol/L ) ; P = 0.001 ] and greater mean ( 95 % CI ) increases in HDL cholesterol [ LC diet : 0.1 mmol/L ( 0.1 , 0.2 mmol/L ) ; HC diet : 0.06 mmol/L ( -0.01 , 0.1 mmol/L ) ; P = 0.002 ] . CONCLUSIONS Both diets achieved substantial weight loss and reduced HbA1c and fasting glucose . The LC diet , which was high in unsaturated fat and low in saturated fat , achieved greater improvements in the lipid profile , blood glucose stability , and reductions in diabetes medication requirements , suggesting an effective strategy for the optimization of T2D management . This trial was registered at www.anzctr.org.au as ACTRN12612000369820 Hypertension is one of the leading causes of morbidity and mortality in Brazil .  Diet may play an important role in reducing blood pressure ( BP ) , as has been shown for diets high in fruits , vegetables and low-fat dairy products and low in salt ( Dietary Approaches to Stop Hypertension (DASH)-Na ) . A low-glycaemic index Brazilian diet combined with the principles of the DASH-Na diet was evaluated in a r and omised study of 206 individuals who were followed for 6 months . In the control group ( CG ) , counselling was based on st and ard care and mainly focused on salt intake reduction . An intention-to-treat analysis showed that , after 6 months , systolic BP was reduced by 14·4 mmHg and diastolic BP by 9·7 mmHg in the experimental group ( EG ) , compared with 6·7 and 4·6 mmHg , respectively , in the CG . After adjusting for body weight , BP at baseline and age , these changes were 12·1 and 7·9 mmHg , respectively . Urinary Na excretion was also reduced by 43·4 mEq/24 h in the EG . Food intake was modified accordingly during the intervention with an increase in the consumption of vegetables  ( 2·97 - 5·85 frequency of consumption measured in three non-consecutive days ) , fruits ( 4·09 - 7·18 ) , beans ( 1·94 - 3·13 ) and fish ( 1·80 - 2·74 ) by the EG . The present study showed the feasibility of a Brazilian dietary approach to treating hypertension by reducing urinary Na excretion and BP , changes that may have a great impact on public health and promote the benefits of controlling hypertension This r and omised controlled trial examined anthropometric changes and cardiovascular benefits of six months of weight management in 110 free living women , aged 18–68 y and BMI 25–50 kg/m2 , who received 1200 kcal/d diet treatments of either high ( 58 % energy , n=57 ) or low ( 35 % energy , n=53 ) carbohydrate ( CHO ) content .  Body weight , plasma total , HDL and LDL cholesterol , triglyceride and blood pressure were measured . Examination at three months showed women on high CHO lost ( mean±s.e.m . ) 4.3±0.5 kg and those on low CHO lost 5.6±0.6 kg of body weight . Changes in risk factors did not significantly differ between the two diet treatments throughout the study . However those on high CHO diets significantly lowered their plasma total cholesterol by 0.33 mmol/l ( 95 % CI : 0.10 , 0.55 ) , LDL cholesterol by 0.23 mmol/l ( 0.02 , 0.43 ) and HDL cholesterol by 0.05 mmol/l ( 0.03 , 0.10 ) , while women on low CHO diets lowered only plasma triglyceride by 0.28 mmol/l ( 0.08 , 0.48 ) . Blood pressure did not change significantly on either diet . After six months , women on high CHO lost 5.6±0.8 kg and those on low CHO lost 6.8±0.8 kg . On the high CHO  diet , total cholesterol remained significantly below the baseline value at 0.34 mmol/l ( 0.13 , 0.56 ) , triglyceride was significantly lowered by 0.27 mmol/l ( 0.10 , 0.45 ) , and HDL cholesterol returned to the baseline value . On the low CHO  diet , triglyceride remained the only risk factor to be significantly improved . A subgroup of 46 postmenopausal women lost significantly ( P<0.05 ) more weight on the low CHO diet than high CHO diet . In conclusion , these results provided some support for preferring a high CHO diet to a lower CHO approach in weight management , from the point of view of risk reduction , but do not indicate a consistently more rapid weight loss with either diet Background Hypertension can be prevented by adopting healthy dietary patterns . Our aim was to assess the 4-year effect on blood pressure ( BP ) control of a r and omized feeding trial promoting the traditional Mediterranean dietary pattern . Methods The PREDIMED primary prevention trial is a r and omized , single-blinded , controlled trial conducted in Spanish primary healthcare centers . We recruited 7,447 men ( aged 55 to 80 years ) and women ( aged 60 to 80 years ) who had high risk for cardiovascular disease . Participants were assigned to a control group or to one of two Mediterranean diets . The control group received education on following a low-fat diet , while the groups on Mediterranean diets received nutritional education and also free foods ; either extra virgin olive oil , or nuts . Trained personnel measured participants ’ BP at baseline and once yearly during a 4-year follow-up . We used generalized estimating equations to assess the differences between groups during the follow-up . Results The percentage of participants with controlled BP increased in all three intervention groups ( P-value for within-group changes : P<0.001 ) . Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group ( −1.53 mmHg ( 95 % confidence interval ( CI ) −2.01 to −1.04 ) for the Mediterranean diet supplemented with extra virgin olive oil , and −0.65 mmHg ( 95 % CI -1.15 to −0.15 ) mmHg for the Mediterranean diet supplemented with nuts ) . No between-group differences in changes of systolic BP were seen . Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP . However , we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group . Trial registration Current Controlled Trials IS RCT BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p<0·001 ) . These differences persisted to 12 months , despite less use of diabetes drugs . Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Abstract Purpose The New Nordic Diet ( NND ) has induced weight loss in a 26-week controlled intervention . We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects . Methods After 26 weeks of intervention with NND or Average Danish Diet ( ADD ) , 147 participants ( mean age 43 years and mean BMI 29.1 kg/m2 ) were followed for further 52 weeks . All participants were encouraged to follow NND but without further guidance . The study is registered with Clinical Trials.gov , study i d NCT01195610 . Results One hundred and ten participants ( 75 % ) completed the follow-up . Among participants previously r and omised to NND ( NND group ) , dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0 , respectively ( both p < 0.0001 ) ( 1–5 point scale ) . Among those originally r and omised to ADD ( ADD group ) , satisfaction with NND was significantly higher than with ADD during follow-up ( 3.3 vs. 2.5 , p = 0.026 ) . Weight losses during intervention of −6.2 kg and −3.0 kg were followed by regains of 4.6 kg ( SE 0.5 ) and 1.1 kg ( SE 0.7 ) for the NND group and ADD group , respectively [ adjusted difference ; mean ( 95 % CI ) : 1.8 kg ( 0.1–3.4 ) , p = 0.041 ] . Across diet groups , every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026 ) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p < 0.0001 ) . Conclusions NND  provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity BACKGROUND To test alternative medicine approaches with a specifically design ed Tibetan dietary and behavioral program in patients with established coronary artery disease ( CAD ) and manifest metabolic syndrome . METHODS This was a r and omized , controlled , double-blinded , parallel group dietary and behavioral intervention study . Between December 2008 and November 2010 , patients were r and omly adjudicated either to evidence -based Western diet ( usual care ) , or to Tibetan diet . We evaluated 524 patients undergoing coronary angiography . All patients were white Caucasian , presented with a body mass index ( BMI ) > 25 kg/m(2 ) , and had evidence of metabolic syndrome . The primary endpoint was change in body weight and BMI at 6 months follow-up . Secondary endpoints included blood pressure , heart rate , intima media thickness , lipids , fasting glucose , glycated hemoglobin , fibrinogen , C-reactive protein ( CRP ) at 6 months follow-up and change in body weight and BMI at 12 months . RESULTS Both groups of patients showed significantly reduced body weight and BMI compared to baseline ( 6 months , usual care weight change : -3.2 ± 3.0 kg ; BMI change : -1.1 ± 1.0 kg/m(2 ) ; Tibetan diet weight change : -6.2 ± 4.4 kg/m(2 ) ; BMI change : -2.1 ± 1.5 kg/m(2 ) ) , but these changes were more pronounced in Tibetan diet compared to usual care ( all , p<0.001 ) . Beneficial effects on weight and BMI were maintained after 12 months of follow-up ( p<0.0001 ) . Levels of total and LDL cholesterols , fibrinogen and CRP were decreased in both groups , but more pronounced in Tibetan diet ( Tibetan diet vs. usual care ( total cholesterol ) : 176.2 ± 43.7 vs. 185.1 ± 47.8 mg/dL ; p=0.024 ; LDL : 111.6 ± 37.8 vs. 119.4 ± 40.9 mg/dL ; p=0.026 ; fibrinogen : 318.3 ± 90.4 vs. 334.1 ± 87.9 mg/dL ; p=0.040 ; CRP : 1.2 ± 3.0 vs. 2.2 ± 4.5mg/dL ; p=0.036 ) . CONCLUSIONS Tibetan diet reduces body weight and BMI in patients with CAD and metabolic syndrome after 6 months significantly better than Western diet and may induce lipid-modifying and anti-inflammatory effects ( Clinical Trials.gov identifier : NCT00810992 ) OBJECTIVE : To compare the long-term compliance and effects of two low-fat diets differing in carbohydrate to protein ratio on body composition and biomarkers of cardiovascular disease risk in obese subjects with hyperinsulinemia . DESIGN : Outpatient , parallel , clinical intervention study of two groups of subjects r and omly assigned to either a st and ard protein ( SP ; 15 % protein , 55 % carbohydrate ) or high-protein ( HP ; 30 % protein , 40 % carbohydrate ) diet , during 12 weeks of energy restriction ( ∼6.5 MJ/day ) and 4 weeks of energy balance ( ∼8.3 MJ/day ) . Subsequently , subjects were asked to maintain the same dietary pattern for the succeeding 52 weeks with minimal professional support . SUBJECTS : A total of 58 obese , nondietetic subjects with hyperinsulinemia ( 13 males/45 females , mean age 50.2 y , mean body mass index ( BMI ) 34.0 kg/m2 , mean fasting insulin 17.8 mU/l ) participated in the study .  MEASUREMENTS : Body composition , blood pressure , blood lipids , fasting glucose , insulin , CRP and sICAM-1 were measured at baseline and at weeks 16 and 68 . Urinary urea/creatinine ratio was measured at baseline , week 16 and at 3 monthly intervals thereafter . RESULTS : In total , 43 subjects completed the study with similar dropouts in each group ( P=0.76 ) . At week 68 , there was net weight loss ( SP −2.9±3.6 % , HP −4.1±5.8 % ; P<0.01 ) due entirely to fat loss ( P<0.001 ) with no diet effect . Both diets significantly increased HDL cholesterol concentrations ( P<0.001 ) and decreased fasting insulin , insulin resistance , sICAM-1 and CRP levels ( P<0.05 ) . Protein intake was significantly greater in HP during the initial 16 weeks ( P<0.001 ) , but decreased in HP and increased in SP during 52-week follow-up , with no difference between groups at week 68 , indicating poor long-term dietary adherence behaviour to both dietary patterns . CONCLUSION : Without active ongoing dietary advice , adherence to dietary intervention is poor . Nonetheless , both dietary patterns achieved net weight loss and improvements in cardiovascular risk factors CONTEXT The scarcity of data addressing the health effects of popular diets is an important public health concern , especially since patients and physicians are interested in using popular diets as individualized eating strategies for disease prevention . OBJECTIVE To assess adherence rates and the effectiveness of 4 popular diets ( Atkins , Zone , Weight Watchers , and Ornish ) for weight loss and cardiac risk factor reduction . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized trial at an academic medical center in Boston , Mass , of overweight or obese ( body mass index : mean , 35 ; range , 27 - 42 ) adults aged 22 to 72 years with known hypertension , dyslipidemia , or fasting hyperglycemia . Participants were enrolled starting July 18 , 2000 , and r and omized to 4 popular diet groups until January 24 , 2002 . INTERVENTION A total of 160 participants were r and omly assigned to either Atkins ( carbohydrate restriction , n=40 ) , Zone ( macronutrient balance , n=40 ) , Weight Watchers ( calorie restriction , n=40 ) , or Ornish ( fat restriction , n=40 ) diet groups . After 2 months of maximum effort , participants selected their own levels of dietary adherence . MAIN OUTCOME MEASURES One-year changes in baseline weight and cardiac risk factors , and self-selected dietary adherence rates per self-report . RESULTS Assuming no change from baseline for participants who discontinued the study , mean ( SD ) weight loss at 1 year was 2.1 ( 4.8 ) kg for Atkins ( 21 [ 53 % ] of 40 participants completed , P = .009 ) , 3.2 ( 6.0 ) kg for Zone ( 26 [ 65 % ] of 40 completed , P = .002 ) , 3.0 ( 4.9 ) kg for Weight Watchers ( 26 [ 65 % ] of 40 completed , P < .001 ) , and 3.3 ( 7.3 ) kg for Ornish ( 20 [ 50 % ] of 40 completed , P = .007 ) . Greater effects were observed in study completers . Each diet significantly reduced the low-density lipoprotein/high-density lipoprotein ( HDL ) cholesterol ratio by approximately 10 % ( all P<.05 ) , with no significant effects on blood pressure or glucose at 1 year . Amount of weight loss was associated with self-reported dietary adherence level ( r = 0.60 ; P<.001 ) but not with diet type ( r = 0.07 ; P = .40 ) . For each diet , decreasing levels of total/HDL cholesterol , C-reactive protein , and insulin were significantly associated with weight loss ( mean r = 0.36 , 0.37 , and 0.39 , respectively ) with no significant difference between diets ( P = .48 , P = .57 , P = .31 , respectively ) . CONCLUSIONS Each popular diet modestly reduced body weight and several cardiac risk factors at 1 year . Overall dietary adherence rates were low , although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group 28 patients who had a sustained diastolic blood pressure of 95 to 104 mm Hg and who had no treatment for it for at least 13 months before the trial , but who were otherwise unselected , took part in a r and omised controlled trial in which the effect of a restricted sodium diet was compared with that of a general health package . The general health package did not include any specific hypotensive procedures . Changes in blood pressure were measured at predetermined intervals over the course of a year . Within each group both systolic and diastolic blood pressure fell to a highly significant extent after a year , but there was no significant difference between the groups . It would thus seem that the antihypertensive effect of a restricted sodium diet may be related to the increased consultation and monitoring activity of such intervention rather than to the dietary manipulation itself OBJECTIVE To evaluate the effects of two low-fat hypocaloric diets differing in the carbohydrate-to-protein ratio , with and without resistance exercise training ( RT ) , on weight loss , body composition , and cardiovascular disease ( CVD ) risk outcomes in overweight/obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 83 men and women with type 2 diabetes ( aged 56.1 ± 7.5 years , BMI 35.4 ± 4.6 kg/m2 ) were r and omly assigned to an isocaloric , energy-restricted diet ( female subjects 6 MJ/day , male subjects 7 MJ/day ) of either st and ard carbohydrate ( CON ; carbohydrate : protein : fat 53:19:26 ) or high protein ( HP ; 43:33:22 ) , with or without supervised RT ( 3 days/week ) for 16 weeks . Body weight and composition , waist circumference ( WC ) , and cardiometabolic risk markers were assessed . RESULTS Fifty-nine participants completed the study . There was a significant group effect ( P ≤ 0.04 ) for body weight , fat mass , and WC with the greatest reductions occuring in HP+RT ( weight [ CON : −8.6 ± 4.6 kg , HP : −9.0 ± 4.8 kg , CON+RT : −10.5 ± 5.1 kg , HP+RT : −13.8 ± 6.0 kg ] , fat mass [ CON : −6.4 ± 3.4 kg , HP : −6.7 ± 4.0 kg , CON+RT : −7.9 ± 3.7 kg , HP+RT : −11.1 ± 3.7 kg ] , and WC [ CON : −8.2 ± 4.6 cm , HP : −8.9 ± 3.9 cm , CON+RT : −11.3 ± 4.6 cm , HP+RT : −13.7 ± 4.6 cm ] ) . There was an overall reduction ( P < 0.001 ) in fat-free mass ( −2.0 ± 2.3 kg ) , blood pressure ( −15/8 ± 10/6 mmHg ) , glucose ( −2.1 ± 2.2 mmol/l ) , insulin ( −4.7 ± 5.4 mU/l ) , A1C ( −1.25 ± 0.94 % ) , triglycerides ( −0.47 ± 0.81 mmol/l ) , total cholesterol ( −0.67 ± 0.69 mmol/l ) , and LDL cholesterol ( −0.37 ± 0.53 mmol/l ) , with no difference between groups ( P ≥ 0.17 ) . CONCLUSIONS An energy-restricted HP diet combined with RT achieved greater weight loss and more favorable changes in body composition . All treatments had similar improvements in glycemic control and CVD risk markers BACKGROUND It is known that obesity , sodium intake , and alcohol consumption factors influence blood pressure . In this clinical trial , Dietary Approaches to Stop Hypertension , we assessed the effects of dietary patterns on blood pressure . METHODS We enrolled 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg . For three weeks , the subjects were fed a control diet that was low in fruits , vegetables , and dairy products , with a fat content typical of the average diet in the United States . They were then r and omly assigned to receive for eight weeks the control diet , a diet rich in fruits and vegetables , or a " combination " diet rich in fruits , vegetables , and low-fat dairy products and with reduced saturated and total fat . Sodium intake and body weight were maintained at constant levels . RESULTS At base line , the mean ( + /-SD ) systolic and diastolic blood pressures were 131.3+/-10.8 mm Hg and 84.7+/-4.7 mm Hg , respectively . The combination diet reduced systolic and diastolic blood pressure by 5.5 and 3.0 mm Hg more , respectively , than the control diet ( P<0.001 for each ) ; the fruits- and -vegetables diet reduced systolic blood pressure by 2.8 mm Hg more ( P<0.001 ) and diastolic blood pressure by 1.1 mm Hg more than the control diet ( P=0.07 ) . Among the 133 subjects with hypertension ( systolic pressure , > or = 140 mm Hg ; diastolic pressure , > or = 90 mm Hg ; or both ) , the combination diet reduced systolic and diastolic blood pressure by 11.4 and 5.5 mm Hg more , respectively , than the control diet ( P<0.001 for each ) ; among the 326 subjects without hypertension , the corresponding reductions were 3.5 mm Hg ( P<0.001 ) and 2.1 mm Hg ( P=0.003 ) . CONCLUSIONS A diet rich in fruits , vegetables , and low-fat dairy foods and with reduced saturated and total fat can substantially lower blood pressure . This diet offers an additional nutritional approach to preventing and treating hypertension Background We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program . Methods Two hundred overweight subjects were r and omly assigned to a conventional low-fat diet and a low-carbohydrate diet group ( target carbohydrate content : > 55 % energy and < 40 % energy , respectively ) . Both groups attended a weekly nutrition education program and dietary counselling by telephone , and had to transfer actual body weight data to our clinic weekly with added Bluetooth ® technology by mobile phone . Various fatness and fat distribution parameters , energy and macronutrient intake , and various biochemical risk markers were measured at baseline and after 6 , and 12 months . Results In both groups , energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months . Macronutrient composition differed significantly between the groups from the beginning to month 12 . At study termination , weight loss was 5.8 kg ( SD : 6.1 kg ) in the low-carbohydrate group and 4.3 kg ( SD : 5.1 kg ) in the low-fat group ( p = 0.065 ) . In the low-carbohydrate group , triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group ( P = 0.005–0.037 ) . Other risk markers improved to a similar extent in both groups . Conclusion Despite favourable effects of both diets on weight loss , the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet . Nevertheless , compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet . Trial registration Clinical trials.gov as Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( < 20 g of carbohydrate daily ; LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p < 0.001 ) compared to the LGID group . Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p < 0.01 ) . Conclusion Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes BACKGROUND The effect of dietary composition on blood pressure is a subject of public health importance . We studied the effect of different levels of dietary sodium , in conjunction with the Dietary Approaches to Stop Hypertension ( DASH ) diet , which is rich in vegetables , fruits , and low-fat dairy products , in persons with and in those without hypertension . METHODS A total of 412 participants were r and omly assigned to eat either a control diet typical of intake in the United States or the DASH diet . Within the assigned diet , participants ate foods with high , intermediate , and low levels of sodium for 30 consecutive days each , in r and om order . RESULTS Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg ( P<0.001 ) during the control diet and by 1.3 mm Hg ( P=0.03 ) during the DASH diet . Reducing the sodium intake from the intermediate to the low level caused additional reductions of 4.6 mm Hg during the control diet ( P<0.001 ) and 1.7 mm Hg during the DASH diet ( P<0.01 ) . The effects of sodium were observed in participants with and in those without hypertension , blacks and those of other races , and women and men . The DASH diet was associated with a significantly lower systolic blood pressure at each sodium level ; and the difference was greater with high sodium levels than with low ones . As compared with the control diet with a high sodium level , the DASH diet with a low sodium level led to a mean systolic blood pressure that was 7.1 mm Hg lower in participants without hypertension , and 11.5 mm Hg lower in participants with hypertension . CONCLUSIONS The reduction of sodium intake to levels below the current recommendation of 100 mmol per day and the DASH diet both lower blood pressure substantially , with greater effects in combination than singly . Long-term health benefits will depend on the ability of people to make long-lasting dietary changes and the increased availability of lower-sodium foods OBJECTIVES A r and omized clinical trial was used to compare the effects of an angiotensin II type 1 receptor inhibitor , c and esartan , singly or in combination with a reducing sodium diet , the DASH diet , on the quality of life ( QOL ) in out patients with hypertension . METHODS After a 2-week wash out period with placebo , 102 patients with mild to moderate hypertension were r and omly assigned to receive c and esartan ( 8 to 16 mg per day ) , and 99 patients were assigned to follow the DASH diet in addition to the same dose of c and esartan , both for 16 weeks . Patients completed the Subjective Symptoms Assessment Profile question naire , just before treatment and at the end of treatment . ANOVA was used to analyze the QOL-score changes over time and compare treatments . RESULTS Resting blood pressures were significantly reduced by the combination of c and esartan and DASH diet ( p < 0.005 ) . Significant improvement was demonstrated for the mental component scores after 16 weeks of treatment with the combination of c and esartan and DASH diet ( p < 0.03 ) . CONCLUSIONS Angiotensin II type 1 receptor blockade with a therapeutic dosage of c and esartan maintains significant control of blood pressure and may improve QOL-scores , especially when combined with a reducing sodium diet Aims /hypothesisThis study compared the long-term weight loss and health outcomes at 1-year follow-up , after a 12-week intensive intervention consisting of two low-fat , weight-loss diets , which differed in protein content . Methods We r and omly assigned 66 obese patients ( BMI : 27–40 kg/m2 ) with Type 2 diabetes to either a low-protein ( 15 % protein , 55 % carbohydrate ) or high-protein diet ( 30 % protein , 40 % carbohydrate ) for 8 weeks of energy restriction ( ~6.7 MJ/day ) and 4 weeks of energy balance . Subjects were asked to maintain the same dietary pattern for a further 12 months of follow-up . Results The study was completed by 38 of the subjects , with equal dropouts in each group . At Week 64 , weight reductions against baseline were −2.2±1.1 kg ( low protein ) and −3.7±1.0 kg ( high protein ) , p<0.01 , with no diet effect . Fat mass was not different from baseline in either group . At Week 12 , both diets reduced systolic and diastolic blood pressure by 6 and 3 mm Hg respectively , but blood pressure increased more with weight regain during follow-up in the low-protein group ( p≤0.04 ) . At Week 64 , both diets significantly increased HDL cholesterol and lowered C-reactive protein concentrations . There was no difference in the urinary urea : creatinine ratio at baseline between the two groups , but this ratio increased at Week 12 ( in the high-protein group only , p<0.001 , diet effect ) , remaining stable during follow-up in both diets . Conclusions /interpretationA high-protein weight-reduction diet may in the long term have a more favourable cardiovascular risk profile than a low-protein diet with similar weight reduction in people with Type 2 diabetes BACKGROUND Patients with high blood pressure ( BP ) often exhibit syndrome X , an aggregation of abnormalities in carbohydrate and lipoprotein metabolism associated with increased risk of coronary heart disease ( CHD ) . The present study evaluated the effects of a 6-month intervention involving either aerobic exercise training alone ( EX only ) or exercise combined with a structured weight loss program ( EX + WL ) on CHD risk factors associated with syndrome X. METHODS A total of 53 men and women were selected from a larger behavioral intervention trial , who showed the hyperinsulinemia , dyslipidemia , and high BP characteristic of syndrome X. Participants were r and omly assigned to EX only ( n = 21 ) , EX + WL ( n = 21 ) , or a waiting list control group ( n = 11 ) . Before and following treatment , participants underwent measurement of  glucose tolerance , lipid levels , and clinical BP . RESULTS Hyperinsulinemic responses to glucose challenge were significantly reduced in both the EX + WL group ( P<.001 ) and the EX-only group ( P = .003 ) . Participants who showed the largest amount of weight loss showed the most robust improvements in abnormal insulin responses ( EX + WL group , 47 % reduction ; EX-only group , 27 % reduction ) . Diastolic BP was significantly reduced in the EX + WL group ( 96 + /- 4 to 87 + /- 5 mm Hg [ mean + /- SD ] ; P = .01 ) , but not in the EX-only group ( 93 + /- 4 to 89 + /- 5 mm Hg [ mean + /- SD ] ; P = .08 ) . Lipid profile was not significantly improved by either intervention . CONCLUSION These results suggest that EX + WL is an effective treatment for hyperinsulinemia and lowering of diastolic BP in patients with the syndrome In a recent communication , ' Poole has proposed that epidemiologists draw an occasional p-value function in order to help them avoid misinterpreting confidence intervals ( CIs ) . Such an exercise might well have some value , and certainly the p-value function does impart more information than a single CI . However , I doubt that such functions are appreciably less subject to misinterpretation than are CIs , and I take strong exception to the suggestion by Poole that my perspective on CIs2 leads to fallacious conclusions that would be averted by a consideration of p-value functions . Poole offers two examples of insights that might be provided by the plotting of  p-value functions .  First , he plots such functions for the two examples given in Figures 1 and 2 ofmy paper.2 From the plots he concludes that " the two point estimates are virtually identical , but one estimate is much more precise than the other . " ' Even the most cursory inspection of my figures would lead to exactly the same conclusion , and I would hope that even without benefit of a picture most readers are able to make similar sense out of reported point estimates and CIs of 2.3 ( 95 per cent CI = 0.4 - 17.3 ) versus 2.5 ( 95 per cent CI = 1.3 - 4.7 ) . The second of Poole 's examples concerns a study of spermicides and Down 's syndrome in which Rothman compared cases to each oftwo control groups.3 In that study , the odds ratio for the comparison between cases and r and om controls was 3.6 ( 90 per cent CI = 1.2 - 9.0 ) , as opposed to 2.8 ( 90 per cent CI = 0.9 - 7.3 ) for the comparison involving controls with congenital heart disease . Although Poole cl aims that the " full utility " of p-value functions  comes when one result is compared with another , I fail to see how in this example inspection of such functions would provide any special insight . It is clear from examination of the point estimates themselves and from the considerable overlap of the CIs that comparison of the cases with the control group that would presumably be subject to a corresponding recall bias yields a result that is not strikingly different from that for the comparison with r and om controls . Consequently , it is difficult to agree with Mills , et al , who have cl aim ed that the results suggest " that recall bias may have caused the higher rate of spermicide use reported in the Down 's group . 4 Poole maintains that an erroneous conclusion such as that of Mills , et al , follows " almost to the letter " my perspective on the interpretation of CIs .  This cl aim is patently false . In fact , I warned explicitly against the very type of fallacious reasoning of which Mills , et al , were guilty . In my discussion of interaction,2 I described the pitfalls OBJECTIVE To examine the effects of a high-carbohydrate low-fat ( HCLF ) and a modified-fat ( MF ) diet on body weight and metabolic control in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) living at home . RESEARCH DESIGN AND METHODS Twenty-four NIDDM patients followed HCLF and MF diets alternately and in r and om order for a 3-month period while at home , with a 1-month baseline and washout between diets . Before and after each diet , fasting glucose and lipids , HbAlc , blood pressure , and body weight were measured . Dietary preferences were assessed by question naire . RESULTS Subjects consumed 50 % of energy as carbohydrate and 23 % as fat on the HCLF diet and 40 % of energy as carbohydrate and 36 % as fat ( over half of which was monounsaturated fat ) on the MF diet . Subjects lost weight on both HCLF and MF diets ( mean loss 0.7 and 1.3 kg , respectively ) . Although the MF diet result ed in a small decrease in fasting glucose levels , there was no significant change in HbA1c . Similarly , there was no significant difference between the diets in changes in blood pressure or fasting blood lipids . Most subjects ( 65 % ) preferred the MF diet . CONCLUSIONS Although the MF diet is not a low-fat diet , it did not appear to facilitate weight gain in subjects with NIDDM living at home . The MF diet provides an alternative for individuals unable to comply with HCLF diets BACKGROUND Although the DASH ( Dietary Approaches to Stop Hypertension ) diet has been shown to lower blood pressure ( BP ) in short-term feeding studies , it has not been shown to lower BP among free-living individuals , nor has it been shown to alter cardiovascular biomarkers of risk . OBJECTIVE To compare the DASH diet alone or combined with a weight management program with usual diet controls among participants with prehypertension or stage 1 hypertension ( systolic BP , 130 - 159 mm Hg ; or diastolic BP , 85 - 99 mm Hg ) . DESIGN AND SETTING R and omized , controlled trial in a tertiary care medical center with assessment s at baseline and 4 months . Enrollment began October 29 , 2003 , and ended July 28 , 2008 . PARTICIPANTS Overweight or obese , unmedicated out patients with high BP ( N = 144 ) . INTERVENTIONS Usual diet controls , DASH diet alone , and DASH diet plus weight management . OUTCOME MEASURES The main outcome measure is BP measured in the clinic and by ambulatory BP monitoring . Secondary outcomes included pulse wave velocity , flow-mediated dilation of the brachial artery , baroreflex sensitivity , and left ventricular mass . RESULTS Clinic-measured BP was reduced by 16.1/9.9 mm Hg ( DASH plus weight management ) ; 11.2/7.5 mm ( DASH alone ) ; and 3.4/3.8 mm ( usual diet controls ) ( P < .001 ) . A similar pattern was observed for ambulatory BP ( P < .05 ) . Greater improvement was noted for DASH plus weight management compared with DASH alone for pulse wave velocity , baroreflex sensitivity , and left ventricular mass ( all P < .05 ) . CONCLUSION For overweight or obese persons with above-normal BP , the addition of exercise and weight loss to the DASH diet result ed in even larger BP reductions , greater improvements in vascular and autonomic function , and reduced left ventricular mass . CLINICAL TRIAL REGISTRATION clinical trials.gov Identifier : NCT00571844 Although aerobic exercise training and diet-induced weight loss each have been shown to individually lower elevated blood pressure ( BP ) , it is currently not known whether their combined use produces an additive antihypertensive effect . In this r and omized clinical trial we therefore compared the effect on resting BP of exercise training only and dietary modification only with that of exercise training plus dietary modification in 55 sedentary , overweight patients with high normal BP or stage 1 or 2 hypertension . After baseline testing , patients were r and omized to 1 of the following 3 interventions for 12 weeks : exercise training only ( aerobic exercise ; 30 to 45 minutes ; 3 to 5 days/week ; 60 % to 85 % of maximal heart rate ) , dietary modification only ( aim ed primarily at weight loss via restriction of energy intake and dietary fat ) , or exercise training plus dietary modification .  Forty-eight patients completed the study . In these patients , exercise training plus dietary modification elicited a greater reduction ( p < or = 0.001 ) in body weight ( -7.1 + /- 2.9 vs -1.0 + /- 1.8 kg ) than exercise training only , and a greater increase ( p < or = 0.05 ) in maximal oxygen uptake ( 4.3 + /- 2.6 vs 1.9 + /- 2.0 ml/kg/min ) versus dietary modification only . However , the reduction in BP with exercise training plus dietary modification ( -12.5 + /- 6.3/7.9 + /- 4.3 mm Hg ) did not differ significantly from that with exercise training only ( -9.9 + /- 6.4/5.9 + /- 4.6 mm Hg ) or dietary modification only ( -11.3 + /- 12.1/7.5 + /- 4.3 mm Hg ) . These data indicate that the antihypertensive effects of exercise training and diet-induced weight loss are not additive . This finding has important public health and clinical implication s for the millions of overweight persons with high normal BP or stage 1 or 2 hypertension OBJECTIVE --To determine the effect of moderate dietary sodium restriction on the hypertension of non-insulin-dependent ( type II ) diabetes . DESIGN --R and omised parallel controlled study of moderate sodium restriction for three months compared with usual diabetic diet , followed by r and omised double blind crossover trial of sustained release preparation of sodium for one month versus placebo for one month in patients continuing with sodium restriction . SETTING -- Patients attending diabetic outpatient clinic of city hospital . PATIENTS --Thirty four patients with established type II diabetes complicated by mild hypertension ( systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 95 mm Hg on three consecutive occasions ) . Patients already taking antihypertensive agents ( but not diuretics ) not barred from study provided that criteria for mild hypertension still met . Conditions precluding patients from study were diabetic or hypertensive nephropathy , cardiac failure , and pregnancy . INTERVENTIONS --After run in phase with recordings at seven weeks , three weeks , and time zero patients were allocated at r and om to receive moderate dietary sodium restriction for three months ( n = 17 ) or to continue with usual diabetic diet . Subsequently nine patients in sodium restriction group continued with regimen for a further two months , during which they completed a r and omised double blind crossover trial of sustained release preparation of sodium ( Slow Sodium 80 mmol daily ) for one month versus matching placebo for one month . END POINT -- Reduction in blood pressure in type II diabetics with mild hypertension . MEASUREMENTS AND MAIN RESULTS --Supine and erect blood pressure , body weight , and 24 hour urinary sodium and potassium excretion measured monthly during parallel group and double blind crossover studies . After parallel group study sodium restriction group showed significant reduction in systolic blood pressure ( supine 19.2 mm Hg , erect 21.4 mm Hg ; p less than 0.001 ) and mean daily urinary sodium excretion ( mean reduction 60 mmol/24 h ) . There were no appreciable changes in weight , diabetic control , or diastolic pressure . No significant changes occurred in controls . In double blind crossover study mean supine systolic blood pressure rose significantly ( p less than 0.005 ) during sodium supplementation ( to 171 mm Hg ) compared with value after three months of sodium restriction alone ( 159.9 mm Hg ) and after one month of placebo ( 161.8 mm Hg ) . CONCLUSIONS --Moderate dietary restriction of sodium has a definite hypotensive effect , which may be useful in mild hypertension of type II diabetes BACKGROUND For many people , maintenance of weight loss is elusive . Whereas high-protein ( HP ) diets have been found to be superior to high-carbohydrate ( HC ) diets for weight loss in the short term , their benefits long term are unclear , particularly for weight maintenance . Furthermore , the literature lacks consensus on the long-term effects of an HP diet on cardiovascular disease risk factors . OBJECTIVE The objective was to investigate whether macronutrient dietary composition plays a role in weight maintenance and in improvement of cardiovascular disease risk factors . DESIGN The study comprised 2 phases . Phase 1 featured a very-low-energy diet for 3 mo . In phase 2 , the subjects were r and omly assigned to an HP or an HC diet for 12 mo . The diets were isocaloric , tightly controlled , and individually prescribed for weight maintenance . The subjects were overweight or obese but otherwise healthy men and women . RESULTS The subjects lost an average of 16.5 kg during phase 1 and maintained a mean ( + /-SEM ) weight loss of 14.5 + /- 1.2 kg ( P < 0.001 ) during phase 2 ; no significant differences between groups were observed . By the end of the study , reductions in systolic blood pressure were 14.3 + /- 2.4 mm Hg for the HP group and 7.7 + /- 2.2 mm Hg for the HC group ( P < 0.045 ) . Forty-seven percent of the 180 subjects who began the study completed both phases . CONCLUSIONS The results indicate that the protein or carbohydrate content of the diet has no effect on successful weight-loss maintenance . A general linear model analysis indicated that dietary treatment ( HP or HC ) was a significant factor in systolic blood pressure change and in favor of the HP diet . This trial was registered at www . clinical trials.gov as NCT 00625236 OBJECTIVE We compared the effects of a low glycemic index ( GI ) diet with the American Diabetes Association ( ADA ) diet on glycosylated hemoglobin ( HbA1c ) among individuals with type 2 diabetes . METHODS Forty individuals with poorly controlled type 2 diabetes were r and omized to a low-GI or an ADA diet . The intervention , consisting of eight educational sessions ( monthly for the first 6 mo and then at months 8 and 10 ) , focused on a low-GI or an ADA diet .  Data on demographics , diet , physical activity , psychosocial factors , and diabetes medication use were assessed at baseline and 6 and 12 mo . Generalized linear mixed models were used to compare the two groups on HbA1c , diabetic medication use , blood lipids , weight , diet , and physical activity .  RESULTS Participants ( 53 % female , mean age 53.5 y ) were predominantly white with a mean body mass index of 35.8 kg/m(2 ) . Although both interventions achieved similar reductions in mean HbA1c at 6 mo and 12 mo , the low-GI diet group was less likely to add or increase dosage of diabetic medications ( odds ratio 0.26 , P = 0.01 ) . Improvements in high-density lipoprotein cholesterol , triacylglycerols , and weight loss were similar between groups . CONCLUSION Compared with the ADA diet , the low-GI diet achieved equivalent control of HbA1c using less diabetic medication . Despite its limited size , this trial suggests that a low-GI diet is a viable alternative to the ADA diet . Findings should be evaluated in a larger r and omized controlled trial Two-hundred- and -twelve untreated subjects ( mean age 52.3 + /- 0.8 years ; 181 males and 31 females ) with a diastolic blood pressure between 90 and 100 mmHg were recruited to the study . Subjects were seen fortnightly and , after 4 pre-diet visits , were r and omized into a normal diet group ( A , 55 subjects ) , a high-potassium diet group ( B , 52 subjects receiving greater than 100 mmol K+/day ) a reduced-sodium diet group ( C , 52 subjects receiving 50 - 75 mmol Na+/day ) or a high-potassium and low-sodium diet group ( D , 53 subjects receiving same Na+ and K+ as groups B and C ) . Two-hundred subjects completed the diet phase of 12 weeks . Urine sodium fell to 86 + /- 7 mmol/day in group C and 73 + /- 6 mmol/day in group D , while daily potassium excretion rose to 96 + /- 5 mmol in group B and 87 + /- 4 mmol in group C. Systolic and diastolic blood pressure fell by 3.8 + /- 1.0 and 1.6 + /- 0.6 mmHg respectively in the normal diet group . The falls in systolic and diastolic blood pressures ( mmHg ) in the diet phase were 7.7 + /- 1.1 and 4.7 + /- 0.7 ( B ) , 8.9 + /- 1.0 and 5.8 + /- 0.6 ( C ) and 7.9 + /- 0.9 and 4.2 + /- 0.7 ( D ) . These falls were all greater than those in the control group on an intention-to-treat analysis ( P less than 0.005 ) but did not differ from each other . Factorial analysis confirmed that the falls in pressure attributable to the low-sodium diet and high-potassium diet were not additive . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To provide a firmer basis for preventing high blood pressure ( BP ) , we tested interventions to promote weight loss , dietary sodium reduction , and their combination for lowering diastolic BP , systolic BP , and the incidence of hypertension during a 3- to 4-year period . METHODS We conducted a r and omized , 2 x 2 factorial , clinical trial , with BP levels measured by blinded observers . Nine academic medical centers recruited 2382 men and women ( age range , 30 - 54 years ) not taking antihypertensive drugs , with a diastolic BP of 83 to 89 mm Hg , a systolic BP lower than 140 mm Hg , and a body mass index ( the weight in kilograms divided by the square of the height in meters ) representing 110 % to 165 % of desirable body weight . Counseling aim ed at helping participants achieve their desirable weight or a 4.5-kg or more weight reduction ( in the weight loss and combined groups ) and /or sodium intake of 80 mmol/d ( in the sodium reduction and combined groups ) was provided . RESULTS From baseline , participants ' weight decreased by 4.3 to 4.5 kg at 6 months and by approximately 2 kg at 36 months in the weight loss and combined groups compared with weight changes in the usual care group ( all groups , P < .001 ) . Sodium excretion decreased 50 and 40 mmol/d at 6 and 36 months , respectively , in the sodium reduction group and about 15 mmol/d less at each time point in the combined group compared with the usual care group ( all groups , P < .01 ) . Compared with the usual care group , BP decreased 3.7/2.7 mm Hg in the weight loss group , 2.9/1.6 mm Hg in the sodium reduction group , and 4.0/2.8 mm Hg in the combined group at 6 months ( all groups , P < .001 ) . At 36 months , BP decreases remained greater in the active intervention groups than in the usual care group ( weight loss group , 1.3/0.9 mm Hg ; sodium reduction group , 1.2/0.7 mm Hg ; combined group , 1.1/0.6 mm Hg ) . Differences were statistically significant for systolic and diastolic BP in the weight loss group and for systolic BP in the sodium reduction group . Through 48 months , the incidence of hypertension ( BP > or = 140 mm Hg systolic or > or = 90 mm Hg diastolic or the use of antihypertensive drugs ) was significantly less in each active intervention group than the usual care group ( average relative risks , 0.78 - 0.82 ) . CONCLUSIONS In overweight adults with high-normal BP , weight loss and reduction in sodium intake , individually and in combination , were effective in lowering systolic and diastolic BP , especially in the short-term ( 6 months ) . Although the effects on average BP declined over time , reductions in hypertension incidence were achieved OBJECTIVE To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes ( NIDDM ) can be significantly improved using a low-fat , vegetarian ( vegan ) diet in the absence of recommendations regarding exercise or other lifestyle changes . METHODS Eleven subjects with NIDDM recruited from the Georgetown University Medical Center or the local community were r and omly assigned to a low-fat vegan diet ( seven subjects ) or a conventional low-fat diet ( four subjects ) . Two additional subjects assigned to the control group failed to complete the study . The diets were not design ed to be isocaloric . Fasting serum glucose , body weight , medication use , and blood pressure were assessed at baseline and biweekly thereafter for 12 weeks . Serum lipids , glycosylated hemoglobin , urinary albumin , and dietary macronutrients were assessed at baseline and 12 weeks . RESULTS Although the sample was intentionally small in accordance with the pilot study design , the 28 % mean reduction in fasting serum glucose of the experimental group , from 10.7 to 7.75 mmol/L ( 195 to 141 mg/dl ) , was significantly greater than the 12 % decrease , from 9.86 to 8.64 mmol/L ( 179 to 157 mg/dl ) , for the control group ( P < 0.05 ) . The mean weight loss was 7.2 kg in the experimental group , compared to 3 . 8 kg for the control group ( P < 0.005 ) . Of six experimental group subjects on oral hypoglycemic agents , medication use was discontinued in one and reduced in three . Insulin was reduced in both experimental group patients on insulin . No patient in the control group reduced medication use . Differences between the diet groups in the reductions of serum cholesterol and 24-h microalbuminuria did not reach statistical significance ; however , high-density lipoprotein concentration fell more sharply ( 0.20 mmol/L ) in the experimental group than in the control group ( 0.02 mmol/L ) ( P < 0.05 ) . CONCLUSION The use of a low-fat , vegetarian diet in patients with NIDDM was associated with significant reductions in fasting serum glucose concentration and body weight in the absence of recommendations for exercise . A larger study is needed for confirmation The present study set out to assess the feasibility of long-term moderate dietary sodium restriction in patients with mild hypertension in general practice . After screening and a run-in phase of 6 - 8 weeks , a total of 77 previously undiagnosed mildly hypertensive patients were identified . Half of them were r and omized to receive a few simple dietary instructions from their general practitioners in order to reduce salt usage ; the others were r and omized to receive no advice . The patients were followed up for 12 months with quarterly visits . A total of 56 patients ( 72.7 % ) completed the study , 26 on a low-sodium diet ( LD ) and 30 on their usual diet ( UD ) . At each visit in the diet phase , patients provided 24h urine , which was analysed for volume and sodium concentration in order to assess their sodium intake . Blood pressure , heart the rate and body weight were recorded . The mean urinary sodium excretion for all diet phase visits overlapped in the two groups ( 177.0 + /- 32.9 vs. 169.3 + /- 49.4 mEq/24h respectively in the LD and UD groups ) . Nevertheless the mean systolic and diastolic blood pressures for all diet phase visits were significantly lower in the LD than in UD group ( 144.2 + /- 11.1/91.6 + /- 6.4 and 148.0 + /- 13.7/95.6 + /- 4.7 mmHg respectively , P less than 0.01 ) . Our data suggest that it is not feasible at present to reduce sodium intake in mild hypertensives with simple and inexpensive dietary instructions , the only ones suitable for widespread application in general practice OBJECTIVE To determine the optimal diet for improving glucose and lipid profiles in obese patients with type 2 diabetes during moderate energy restriction . RESEARCH DESIGN AND METHODS A total of 35 free-living obese patients with type 2 diabetes were assigned to one of three 1,600 kcal/day diets for 12 weeks . The diets were high carbohydrate ( 10 % fat , 4 % saturated ) , high monounsaturated fat ( MUFA ) ( 32 % fat , 7 % saturated ) , or high saturated fat ( SFA ) ( 32 % fat , 17 % saturated ) . RESULTS Diet composition did not affect the magnitude of weight loss , with subjects losing an average of 6.6 + /- 0.9 kg . Energy restriction and weight loss result ed in reductions in fasting plasma glucose ( -14 % ) , insulin ( -27 % ) , GHb ( -14 % ) , and systolic ( -7 % ) and diastolic blood pressure ( -10 % ) levels and the glucose response area ( -17 % ) independent of diet composition . Diet composition did affect the lipoprotein profile . LDL was 10 % and 17 % lower with the high-carbohydrate and high-MUFA diets , respectively , whereas no change was observed with the high-SFA diet ( P < 0.001 for effect of diet ) . HDL was transiently reduced on the high-carbohydrate diet at weeks 1 , 4 , and 8 , whereas higher fat consumption maintained these levels . The total cholesterol : HDL ratio , although significantly reduced on the high-MUFA diet ( P < 0.01 ) , was not different from the other two diets after adjustment for baseline differences . CONCLUSIONS Energy restriction , independent of diet composition , improves glycemic control ; however , reducing SFA intake by replacing SFA with carbohydrate or MUFA reduces LDL maximally during weight loss and to a greater degree than has been shown in weight-stable studies CONTEXT Nonpharmacologic interventions are frequently recommended for treatment of hypertension in the elderly , but there is a paucity of evidence from r and omized controlled trials in support of this recommendation . OBJECTIVE To determine whether weight loss or reduced sodium intake is effective in the treatment of older persons with hypertension . DESIGN R and omized controlled trial . PARTICIPANTS A total of 975 [ corrected ] men and women aged 60 to 80 years with systolic blood pressure lower than 145 mm Hg and diastolic blood pressure lower than 85 mm Hg while receiving treatment with a single antihypertensive medication . SETTING Four academic health centers . INTERVENTION The 585 obese participants were r and omized to  reduced sodium intake , weight loss , both , or usual care , and the 390 nonobese participants were r and omized to reduced sodium intake or usual care . Withdrawal of antihypertensive medication was attempted after 3 months of intervention . MAIN OUTCOME MEASURE Diagnosis of high blood pressure at 1 or more follow-up visits , or treatment with antihypertensive medication , or a cardiovascular event during follow-up ( range , 15 - 36 months ; median , 29 months ) . RESULTS The combined outcome measure was less frequent among those assigned vs not assigned to reduced sodium intake ( relative hazard ratio , 0.69 ; 95 % confidence interval [ CI ] , 0.59 - 0.81 ; P<.001 ) and , in obese participants , among those assigned vs not assigned to weight loss ( relative hazard ratio , 0.70 ; 95 % CI , 0.57 - 0.87 ; P<.001 ) . Relative to usual care , hazard ratios among the obese participants were 0.60 ( 95 % CI , 0.45 - 0.80 ; P<.001 ) for reduced sodium intake alone , 0.64 ( 95 % CI , 0.49 - 0.85 ; P=.002 ) for weight loss alone , and 0.47 ( 95 % CI , 0.35 - 0.64 ; P<.001 ) for  reduced sodium intake and weight loss combined . The frequency of cardiovascular events during follow-up was similar in each of the 6 treatment groups . CONCLUSION Reduced sodium intake and weight loss constitute a feasible , effective , and safe nonpharmacologic therapy of hypertension in older persons OBJECTIVE This study sought to examine the effects of a 3-month programme of dietary advice to restrict carbohydrate intake compared with reduced-portion , low-fat advice in obese subjects with poorly controlled Type 2 diabetes . RESEARCH DESIGN AND METHODS One hundred and two patients with Type 2 diabetes were recruited across three centres and r and omly allocated to receive group education and individual dietary advice .  Weight , glycaemic control , lipids and blood pressure were assessed at baseline and 3 months . Dietary quality was assessed at the end of study . RESULTS Weight loss was greater in the low-carbohydrate ( LC ) group ( -3.55 + /- 0.63 , mean + /- sem ) vs. -0.92 + /- 0.40 kg , P = 0.001 ) and cholesterol : high-density lipoprotein ( HDL ) ratio improved ( -0.48 + /- 0.11 vs. -0.10 + /- 0.10 , P = 0.01 ) . However , relative saturated fat intake was greater ( 13.9 + /- 0.71 vs. 11.0 + /- 0.47 % of dietary intake , P < 0.001 ) , although absolute intakes were moderate . CONCLUSIONS Carbohydrate restriction was an effective method of achieving short-term weight loss compared with st and ard advice , but this was at the expense of an increase in relative saturated fat intake BACKGROUND Some cross-sectional studies suggest that fiber and protein intake can be associated with lower levels of blood pressure , but results from prospect i ve cohorts are scarce and none has been conducted outside the U.S. METHODS The SUN cohort followed-up prospect ively 5880 Spanish men and women older than 20 years of age , all university graduates . Dietary information was gathered at baseline with a previously vali date d semiquantitative food frequency question naire . New cases of medically diagnosed hypertension ( HT ) were identified through responses to a mailed question naire after at least 2 years from recruitment . RESULTS One hundred and eighty new cases of HT were ascertained after a median follow-up of 28 months . After adjustment for potential confounders and several dietary factors , participants in the highest quintile of vegetable protein intake had a lower risk of incident HT compared with those in the lowest quintile [ hazard ratio ( HR ) = 0.5 , 95 % confidence interval ( CI ) 0.2 - 0.9 , p for trend = 0.06 ] . Similarly , fiber from cereals was inversely associated with a lower risk of HT ( HR comparing fifth vs. first quintile = 0.6 , 95 % CI 0.3 - 1.0 , p for trend = 0.05 ) . Risk reduction was more important among men and obese and older individuals . Total or animal protein and total fiber as well as fiber from other sources different from cereal were not associated with the risk of HT . CONCLUSIONS In this Mediterranean cohort , dietary intake of vegetable protein and fiber from cereals was associated with a lower risk of HT when other nutrients were also taken into consideration Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P<0.001 ) but not at 24 months ( P=0.095 ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P<0.001 , respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P<0.001 and P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in  the PD group . The long-term consequences of these changes remain to be studied 1 . Three groups of young patients with borderline hypertension were studied for a 12 months period . The first was on a free sodium diet while the second was on a low-salt diet . The third group of patients underwent acute salt loading . 2 . After 12 months the group on free diet showed a significant increase of intralymphocytic sodium but no change in blood pressure was noted . Five patients who were re-checked after 24 months also had a significant increase in blood pressure . 3 . Patients treated with a low-salt diet showed a significant decrease of both intralymphocytic sodium concentration and blood pressure . 4 . After acute salt loading , borderline subjects with high intralymphocytic sodium showed a significant greater natriuresis whereas intralymphocytic sodium increased only in those subjects in whom it was initially normal Ninety four patients with mild hypertension ( average supine diastolic blood pressure ( phase V ) 95 - 110 mm Hg ) were allocated at r and om to receive restriction of dietary sodium ( maximum allowed 70 mmol(mEq)/24 h ) or a normal diet . In addition , they received in r and om order 25 mg chlorthalidone , 200 mg metoprolol ( slow release ) , and a fixed combination of these two drugs . Each drug treatment was given for four weeks and alternated with four weeks of placebo . Forty four patients were allocated to sodium restriction ( group 1 ) and 50 to normal diet ( group 2 ) . The mean 24 hour urinary sodium excretion in group 1 was 74 ( SD 31 ) mmol(mEq)/24 h , and in group 2 132 ( 51 ) mmol/24 h. Compared with the screening blood pressure the average decrement of the supine blood pressure in group 1 was 16.0/8.6 mm Hg with placebo , 21.7/11.5 mm Hg with the diuretic , 28.5/17.8 mm Hg with the beta blocker , and 28.9/18.4 mm Hg with the combined agent ; in group 2 these values were 13.3/6.1 , 20.3/9.7 , 21.3/12.9 , and 29.4/16.8 mm Hg , respectively . There was a sharp decrease of the average potassium concentration during chlorthalidone and combination treatment periods ( average value 3.3 mmol(mEq)/1 ) . These results suggest that moderate salt restriction used as sole treatment has a limited though demonstrable blood pressure lowering effect but that when it is used as an adjuvant to beta blocker treatment its value is greatly enhanced CONTEXT Weight loss , sodium reduction , increased physical activity , and limited alcohol intake are established recommendations that reduce blood pressure ( BP ) . The Dietary Approaches to Stop Hypertension ( DASH ) diet also lowers BP . To date , no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations . OBJECTIVE To determine the effect on BP of 2 multicomponent , behavioral interventions . DESIGN , SETTING , AND PARTICIPANTS R and omized trial with enrollment at 4 clinical centers ( January 2000-June 2001 ) among 810 adults ( mean [ SD ] age , 50 [ 8.9 ] years ; 62 % women ; 34 % African American ) with above-optimal BP , including stage 1 hypertension ( 120 - 159 mm Hg systolic and 80 - 95 mm Hg diastolic ) , and who were not taking antihypertensive medications . INTERVENTION Participants were r and omized to one of 3 intervention groups : ( 1 ) " established , " a behavioral intervention that implemented established recommendations ( n = 268 ) ; ( 2 ) " established plus DASH,"which also implemented the DASH diet ( n = 269 ) ; and ( 3 ) an " advice only " comparison group ( n = 273 ) . MAIN OUTCOME MEASURES Blood pressure measurement and hypertension status at 6 months . RESULTS Both behavioral interventions significantly reduced weight , improved fitness , and lowered sodium intake . The established plus DASH intervention also increased fruit , vegetable , and dairy intake . Across the groups , gradients in BP and hypertensive status were evident . After subtracting change in advice only , the mean net reduction in systolic BP was 3.7 mm Hg ( P<.001 ) in the established group and 4.3 mm Hg ( P<.001 ) in the established plus DASH group ; the systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg ( P = .43 ) . Compared with the baseline hypertension prevalence of 38 % , the prevalence at 6 months was 26 % in the advice only group , 17 % in the established group ( P = .01 compared with the advice only group ) , and 12 % in the established plus DASH group ( P<.001 compared with the advice only group ; P = .12 compared with the established group ) . The prevalence of optimal BP ( < 120 mm Hg systolic and < 80 mm Hg diastolic ) was 19 % in the advice only group , 30 % in the established group ( P = .005 compared with the advice only group ) , and 35 % in the established plus DASH group ( P<.001 compared with the advice only group ; P = .24 compared with the established group ) . CONCLUSION Individuals with above-optimal BP , including stage 1 hypertension , can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk The purpose of this study was to investigate the effect of 1-year diet intervention , exercise intervention and both combined on blood pressure ( BP ) in normotensives and mild hypertensives . Two hundred and nineteen sedentary middle aged men and women with slightly deranged coronary heart disease ( CHD ) risk factors were r and omised to a control , a diet , an exercise and a diet + exercise group . Based on baseline diastolic BP , participants were divided into tertiles , giving baseline average BP of 141.4/96.7 in tertile 1 , 130.7/87.6 in tertile 2 and 121.9/79.0 in tertile 3 . The 1-year net-difference in BP between the intervention groups and the control group decreased across the tertiles ; in tertile 1 being -11.2/-6.7 ( p < 0.05 ) , -11.3/-6.7 ( p < 0.05 for systolic BP only ) and -7.0/-5.1 ( NS ) in the combined , diet and exercise group respectively . Triglycerides , HDL cholesterol , and insulin variables were significantly and favourably changed , the changes being most marked in the combined group . The results show that diet and diet + exercise are about equally effective in reducing BP , and the effects may be dependent on the baseline level . Within the upper tertile of baseline BP , the decline in BP in the combined intervention and the diet group are almost comparable to those obtained with drug treatment . In addition , other important CHD risk factors were all changed in a beneficial direction Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment . Design R and omised controlled trial . Setting Dunedin , New Zeal and . Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin ( HbA1c ) of more than 7 % despite optimised drug treatments plus at least two of overweight or obesity , hypertension , and dyslipidaemia . Intervention Intensive individualised dietary advice ( according to the nutritional recommendations of the European Association for the Study of Diabetes ) for six months ; both the intervention and control participants continued with their usual medical surveillance . Main outcome measures HbA1c was the primary outcome . Secondary outcomes included measures of adiposity , blood pressure , and lipid profile . Results After adjustment for age , sex , and baseline measurements , the difference in HbA1c between the intervention and control groups at six months ( −0.4 % , 95 % confidence interval −0.7 % to −0.1 % ) was highly statistically significant ( P=0.007 ) , as were the decreases in weight ( −1.3 kg , −2.4 to −0.1 kg ; P=0.032 ) , body mass index ( −0.5 , −0.9 to −0.1 ; P=0.026 ) , and waist circumference ( −1.6 cm , −2.7 to −0.5 cm ; P=0.005 ) . A decrease in saturated fat ( −1.9 % total energy , −3.3 % to −0.6 % ; P=0.006 ) and an increase in protein ( 1.6 % total energy , 0.04 % to 3.1 % ; P=0.045 ) in the intervention group were the most striking differences in nutritional intake between the two groups . Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment . Trial registration Clinical trials NCT00124553 Context Can adults make sustained changes in unhealthy lifestyle behaviors ? Content In this multicenter trial , 810 adult volunteers with prehypertension or stage 1 hypertension were r and omly assigned to a multicomponent behavioral intervention group , a group combining the behavioral intervention plus the Dietary Approaches to Stop Hypertension ( DASH ) diet , or an advice only group . At 18 months , participants in both behavioral intervention groups had less hypertension , more weight loss , and better reduction in sodium and fat intake than those receiving advice only . The participants in the DASH diet group also increased their intake of fruits , vegetables , and fiber . Implication s Motivated adults can sustain several lifestyle changes over 18 months , which might reduce their risk for cardiovascular disease . The Editors The public health burden of chronic diseases related to suboptimal diet and physical inactivity is enormous . It has been estimated that these lifestyle factors contribute to approximately 20 % of deaths in the United States ( 1 ) . Incidence of atherosclerotic cardiovascular disease , overweight and obesity , elevated blood pressure and lipid levels , diabetes , osteoporosis , and cancer is increased by unhealthy lifestyles ( 2 - 8 ) . Multiple lifestyle factors , such as physical inactivity ; excessive intake of calories , sodium , saturated fat , and cholesterol ; and inadequate intake of fruits , vegetables , and low-fat dairy products , are etiologically related to the development of these diseases ( 4 , 5 , 8 - 10 ) . To reduce the burden of chronic disease , increased physical activity and changes in diet are needed , yet few intervention studies have attempted to achieve many lifestyle changes simultaneously . The PREMIER r and omized trial tested the effects of 2 multicomponent behavioral interventions on blood pressure ( 11 ) . Both interventions promoted increased physical activity , weight loss , and reduced sodium intake , each of which is recommended by the 2005 Dietary Guidelines Scientific Advisory Committee ( 12 ) . One intervention also added the Dietary Approaches to Stop Hypertension ( DASH ) diet ( 13 ) . This diet , which is high in fruits , vegetables , and low-fat dairy products and low in saturated fat , total fat , and cholesterol , meets each of the major nutrient recommendations that were established by the Institute of Medicine ( 14 - 18 ) . We report the effects of the PREMIER interventions on lifestyle changes and blood pressure status at 18 months . The main results of PREMIER , namely change in blood pressure at 6 months , were reported previously ( 11 ) . Methods The PREMIER study design and rationale ( 19 ) and intervention methods ( 11 ) have been described previously . The institutional review boards at each clinical center ; an external protocol review committee appointed by the National Heart , Lung , and Blood Institute ( NHLBI ) ; and the NHLBI review ed and approved the protocol ( available at www.kpchr.org/public/premier/intervention/default.asp ) . The NHLBI also appointed a data and safety monitoring board to monitor the trial . Each participant provided written informed consent . The trial was conducted from January 2000 through November 2002 . Study Participants Participants were generally healthy adults , age 25 years or older , who had prehypertension or stage 1 hypertension and met the Joint National Committee VI ( JNC VI ) criteria for a 6-month trial of nonpharmacologic therapy ( 2 ) . Targeted recruitment methods were used to ensure adequate representation of clinical ly important subgroups , in particular , African-American persons . Specific methods varied from site to site but included direct mailings , radio and newspaper advertisements , and networking within the local African-American communities . Eligibility criteria included not taking antihypertensive medication and having a systolic blood pressure of 120 to 159 mm Hg and a diastolic blood pressure of 80 to 95 mm Hg , based on the average of 3 screening visits . Persons with prehypertension ( systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg ) were included because of the excess risk for cardiovascular disease in those with blood pressure within this range ( 20 ) . Major exclusion criteria were a body mass index less than 18.5 kg/mg2 or greater than 45.0 kg/m2 , use of antihypertensive drugs or other drugs that affect blood pressure , JNC VI risk category C ( target organ damage or diabetes ) , use of prescription weight loss medications , previous cardiovascular event , congestive heart failure , angina , cancer , and consumption of more than 21 alcoholic drinks per week . Trial Conduct Eligible participants were r and omly assigned , with equal probability , to 1 of 3 groups : an advice only comparison group ( advice only ) ; an intervention group that targeted established , guideline -recommended lifestyle recommendations ( established ) ( 2 ) ; or an intervention group targeting the established recommendations and adding the DASH dietary pattern ( established plus DASH ) ( 13 ) . Computer-generated treatment assignments were stratified by clinic and hypertension status and were assigned in blocks of varying sizes to provide balance over time . The actual assignments were administered by using a password-protected , Web-based application developed by the coordinating center and accessible only by authorized individuals . All clinic measurement staff were blinded to treatment assignment , and all intervention staff were blinded to clinic measurements . Hypertension was defined by using the JNC VI criteria for hypertension treatment : an average systolic blood pressure of 140 mm Hg , a diastolic blood pressure greater than 90 mm Hg , or use of antihypertensive medication . Normal blood pressure was defined as systolic blood pressure less than 120 mm Hg , diastolic blood pressure less than 80 mm Hg , and no use of antihypertensive medication ( 21 ) ( Figure ) . Intervention was provided by master 's degreelevel counselors ( dietitians and health educators trained in behavioral methods ) . The counselors were central ly trained before the start of the study , attended annual 3-day training sessions , and participated in monthly conference calls . Figure . Flow diagram of enrollment , measurements , and visit completion . Advice Only  Group Participants in the advice group  received advice to follow the National High Blood Pressure Education Program lifestyle recommendations for blood pressure control ( 2 ) . Lifestyle recommendations included reducing weight ( if overweight ) , following a reduced-sodium diet , engaging in regular moderate-intensity physical activity , and eating a heart-healthy diet , including the DASH diet . This advice was provided in two 30-minute individual sessions , 1 immediately after r and om assignment and 1 after the 6-month data collection visit . A PREMIER counselor review ed the guidelines with the participant and provided printed educational material s and information about community re sources . This intervention did not include advice to keep a food or exercise diary . Behavioral Interventions in the Established and Established plus DASH Groups Participant goals for the established and established plus DASH groups included weight loss of at least 6.8 kg ( 15 lb ) for those with a body mass index of 25 kg/m2 or greater , at least 180 minutes per week of moderate-intensity physical activity , no more than 100 mmol per day of dietary sodium , and alcohol consumption of no more than 30 mL ( 1 oz ) per day ( 2 drinks ) for men and 15 mL ( 0.5 ) oz per day ( 1 drink ) for women . Participants assigned to the established plus DASH group ( but not those in the established group ) also received counseling on the DASH diet , with goals for increased consumption of fruits and vegetables ( 9 to 12 servings/d ) and low-fat dairy products ( 2 to 3 servings/d ) and reduced consumption of saturated fat ( 7 % of energy ) and total fat ( 25 % of energy ) . The intervention format , contact pattern , and behavior change strategies for the established and established plus DASH groups were identical . During the first 6 months , participants in both behavioral intervention groups attended 14 group sessions and 4 individual sessions ; during months 7 to 18 , they attended monthly group sessions supplemented with 3 individual counseling sessions . Throughout the trial , participants in the established and established plus DASH groups ( but not those in the advice group ) kept food diaries , monitored dietary calorie and sodium intakes , and recorded minutes of physical activity . Self-monitoring was used to provide individualized feedback , reinforcement , problem solving , and support . Social support for initial behavior changes and maintenance of change was provided during the group sessions . More detailed descriptions of the behavorial intervention methods are available ( 22 ) . Measurements Blood pressure was assessed twice at each measurement , and systolic and diastolic blood pressures were calculated by using the mean of all available measurements ( 4 sets before r and om assignment , 3 sets at 6 and 18 months , and 1 set at 3 and 12 months ) . For 4 participants who were started on antihypertensive drug therapy between the 12- and 18-month visits , we obtained an official set of blood pressure measurements before initiation of therapy and used these as our 18-month blood pressure values for analysis . A similar procedure was used to obtain the 6-month blood pressure value for the 1 participant who began taking antihypertensive drugs between the 3- and 6-month visits . Two 24-hour dietary recalls , 1 obtained on a weekday and the other obtained on a weekend , were collected at baseline and at 6 and 18 months by telephone interview ( 23 ) . Intakes of nutrients and food groups were calculated by using the Nutrition Data System for Research , version NDS-R 1998 ( University of Minnesota , Minneapolis , Minnesota ) . Urinary excretion of sodium ( reflecting salt intake ) and potassium ( reflecting fruit and vegetable intake ) was obtained from 24-hour urinary collection s at baseline Low-carbohydrate diets have been associated with significant reductions in weight and HbA(1c ) in obese , diabetic participants who received high-intensity lifestyle modification for 6 or 12 months . This investigation sought to determine whether comparable results to those of short-term , intensive interventions could be achieved over a 24-month study period using a low-intensity intervention that approximates what is feasible in outpatient practice . A total of 144 obese , diabetic participants were r and omly assigned to a low-carbohydrate diet ( < 30 g/day ) or to a low fat diet ( < or=30 % of calories from fat with a deficit of 500 kcal/day ) . Participants were provided weekly group nutrition education sessions for the first month , and monthly sessions thereafter through the end of 24 months . Weight , HbA(1c ) , glucose , and lipids were measured at baseline and 6 , 12 , and 24 months . Of the 144 enrolled participants , 68 returned for the month 24 assessment visit .  Weights were retrieved from electronic medical records for an additional 57 participants ( total , 125 participants ) at month 24 . All participants with a baseline measurement and at least one of the three other measurements were included in the mixed-model analyses ( n = 138 ) . The low-intensity intervention result ed in modest weight loss in both groups at month 24 . At this time , participants in the low-carbohydrate group lost 1.5 kg , compared to 0.2 kg in the low-fat group ( P = 0.147 ) . Lipids , glycemic indexes , and dietary intake did not differ between groups at month 24 ( or at months 6 or 12 ) ( Clinical Trials.gov number , NCT00108459 ) BACKGROUND The blood pressure-lowering mechanism of low-sodium diet is not fully understood . METHODS We assessed the effects of salt restriction on cardiac parasympathetic function as measured by heart-rate variability ( HRV ) in mild to moderate hypertensive patients . Eighty patients were r and omized to a 6-month low- ( N = 40 ) or normal ( N = 40 ) sodium diet and a 24-h electrocardiogram ( ECG ) was carried out in the beginning of the study and at 6 months . Five time-domain and six frequency-domain HRV variables were analyzed : mean RR interval , st and ard deviation of normal RR intervals , mean of the st and ard deviations of all RR intervals for 5-min segments of the entire recording , percentage of differences between adjacent normal RR intervals exceeding 50 ms , square root of the mean of squared differences between adjacent normal RR intervals , total ( 0.01 - 0.40 Hz ) , high frequency ( HF , 0.15 - 0.40 Hz ) , low frequency ( LF , 0.04 - 0.15 Hz ) , very LF ( 0.01 - 0.04 Hz ) and LF/HF ratio . RESULTS Although blood pressure diminished significantly ( systolic blood pressure ( SBP ) from 149.9 + /- 14.7 mm Hg to 130.3 + /- 11.8 mm Hg , P < 0.001 and diastolic blood pressure ( DBP ) from 98.0 + /- 6.4 mm Hg to 87.1 + /- 6.2 mm Hg , P < 0.001 ) after 6 months in the salt reduction group , no significant differences in the change between the groups could be detected . CONCLUSIONS A moderate , prolonged dietary sodium restriction does not alter HRV . Therefore , mechanisms other than cardiac autonomic mechanisms are likely to predominate in the blood pressure-lowering effect of salt restriction OBJECTIVE Conflicting evidence exists as to weight loss produced by diets with different carbohydrate/protein ratio . The aim was to compare the long-term effects of high-protein vs. high-carbohydrate diet ( HPD , HCD ) , combined with cognitive behavior therapy ( CBT ) . DESIGN AND METHODS In a r and omized trial , 88 obese participants ( mean age , 46.7 ; mean BMI , 45.6 kg m(-2 ) ) were enrolled in a 3-week inpatient and 48-week outpatient treatment , with continuous CBT during the study period . All subjects consumed a restricted diet ( 1,200 kcal day(-1 ) for women , 1,500 for men ; 20 % energy from fat , < 10 % saturated fat ) . HPD derived 34 % energy from proteins , 46 % from carbohydrates ; HCD 17 % from proteins , 64 % from carbohydrates . The primary outcome was 1-year percent weight loss . Secondary outcomes were attrition rates and changes in cardiovascular risk factors and psychological profile . RESULTS Attrition rates were similar between groups ( 25.6 % ) . In the intention-to-treat analysis , weight loss averaged 15.0 % in HPD and 13.3 % in HCD at 1 year , without any difference throughout the study period . Both diets produced a similar improvement in secondary outcomes . CONCLUSIONS The relative carbohydrate and protein content of the diet , when combined with intensive CBT , does not significantly affect attrition rate , weight loss and psychosocial outcome in patients with severe obesity BACKGROUND AND AIMS To investigate the impact of a diet modeled on the traditional Cretan Mediterranean diet on metabolic control and vascular risk in type 2 diabetes . METHODS AND RESULTS Twenty-seven subjects ( 47 - 77 yrs ) with type 2 diabetes were r and omly assigned to consume either the intervention diet ad libitum or their usual diet for 12 weeks and then cross over to the alternate diet . Most of the meals and staple foods for the intervention diet were provided . Lipids , glycemic variables , blood pressure , homocysteine , C-reactive protein , plasma carotenoids and body composition ( anthropometry and dual energy X-ray absorptiometry ) were assessed at baseline , and at the end of both diet periods . Dietary adherence was monitored using plasma carotenoid and fatty acid ( FA ) analysis , complemented by diet diaries . Compared with usual diet , on the ad libitum Mediterranean intervention diet glycosylated haemoglobin fell from 7.1 % ( 95 % CI : 6.5 - 7.7 ) to 6.8 % ( 95 % CI : 6.3 - 7.3 ) ( p=0.012 ) and diet quality improved significantly [ plant : animal ( g/day ) food ratio increased from 1.3 ( 95 % CI : 1.1 - 1.5 ) to 5.4 ( 95 % CI : 4.3 - 6.6 ) ( p<0.001 ) ] , plasma lycopene and lutein/zeaxanthin increased ( 36 % and 25 % , respectively ) , plasma saturated and trans FAs decreased , and monounsaturated FAs increased . CONCLUSION A traditional moderate-fat Mediterranean diet improves glycemic control and diet quality in men and women with well-controlled type 2 diabetes , without adverse effects on weight
target: For most comparisons , the credibility of evidence was rated very low to moderate , with the exception for the DASH vs. the low-fat dietary approach for which the quality of evidence was rated high .
  Conclusion : The present network meta- analysis suggests that the DASH dietary approach might be the most effective dietary measure to reduce blood pressure among hypertensive and pre-hypertensive patients based on high quality evidence
background: ABSTRACT Background : Pairwise meta-analyses have shown beneficial effects of individual dietary approaches on blood pressure but their comparative effects have not been established .
  Objective : Therefore we performed a systematic review of different dietary intervention trials and estimated the aggregate blood pressure effects through network meta- analysis including hypertensive and pre-hypertensive patients .