title: Energy intake is associated with endotoxemia in apparently healthy men. Resistant dextrin, as a prebiotic, improves insulin resistance and inflammation in women with type 2 diabetes: a randomised controlled clinical trial. The Therapeutic Potential of Resistant Starch in Modulation of Insulin Resistance, Endotoxemia, Oxidative Stress and Antioxidant Biomarkers in Women with Type 2 Diabetes: A Randomized Controlled Clinical Trial The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic® on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults Effects of NUTRIOSE® dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men Is there any place for resistant starch, as alimentary prebiotic, for patients with type 2 diabetes? Amylose resistant starch (HAM-RS2) supplementation increases the proportion of Faecalibacterium bacteria in end-stage renal disease patients: Microbial analysis from a randomized placebo-controlled trial. High-Resistant Starch, Low-Protein Flour Intervention on Patients With Early Type 2 Diabetic Nephropathy: A Randomized Trial.
abstract: BACKGROUND The bridge between food intake and weight is not fully understood . Recently , the role of gut microbiota and bacterial lipopolysacharides ( LPS ) in weight has been noted . OBJECTIVE The objective was to evaluate the relation between plasma LPS concentration and food intake . DESIGN A dietary survey was conducted in 1015 subjects r and omly recruited in France . The participants were given oral and written instructions on how to keep a consecutive 3-d food record . Plasma LPS was measured in a sub sample of 201 men . To assess , under controlled conditions , the differential impact of various high-energy diets , plasma LPS concentrations were measured in mice fed a high-fat or a high-carbohydrate diet over a 4-wk period . RESULTS In humans , no significant relation was observed between cardiovascular disease risk factors , carbohydrate and protein intakes , and plasma LPS concentration . Conversely , positive correlations were observed with fat and energy intakes . In a multivariate analysis , endotoxemia was independently associated with energy intake . Compared with the control mice , mice fed a high-energy diet showed an increase in plasma LPS . However , in mice fed a high-carbohydrate diet , the increase in plasma LPS was blunted compared with mice fed a high-fat diet . CONCLUSIONS In this large sample of healthy men from a population -based sample , we found a link between food intake and plasma LPS . Experimental data suggest that fat was more efficient in transporting bacterial LPS from the gut lumen into the bloodstream . The results of this study add to the knowledge of mechanisms responsible for relations between food intake and metabolic diseases Improvement of insulin resistance and inflammation is a basic strategy in the management of type 2 diabetes . There is limited evidence that prebiotics improve insulin resistance and inflammation . However , the ameliorating effect of resistant dextrin , as a prebiotic , on insulin resistance and inflammation in patients with type 2 diabetes has not been investigated so far . Therefore , the present study aim ed to examine the effects of resistant dextrin on insulin resistance and inflammation in type 2 diabetic patients . In a r and omised controlled clinical trial , fifty-five women with type 2 diabetes were assigned to two groups : the intervention group ( n 30 ) and the control group ( n 25 ) . The intervention group received a daily supplement of 10 g resistant dextrin and the control group received a similar amount of maltodextrin as placebo for 8 weeks . Fasting plasma glucose ( FPG ) , HbA1c , insulin , high-sensitivity C-reactive protein ( hs-CRP ) , IL-6 , TNF-α , malondialdehyde ( MDA ) and serum endotoxin concentrations were measured before and after the intervention . Data were analysed using SPSS ( version 13 ) . Paired and unpaired t tests and ANCOVA were used to compare quantitative variables after the intervention . Patients supplemented with resistant dextrin exhibited a significant decrease in fasting insulin ( 20.1 pmol/l , 22.8 % ) , homeostasis model assessment of insulin resistance ( 1.3 , 24.9 % ) , quantitative insulin sensitivity check index ( 0.2 , 7.2 % ) , IL-6 ( 1.4 pg/ml , 28.4 % ) , TNF-α ( 5.4 pg/ml , 18.8 % ) , MDA ( 1.2 nmol/ml , 25.6 % ) and endotoxin ( 6.2 endotoxin units/ml , 17.8 % ) concentrations than those supplemented with maltodextrin ( P < 0.05 ) . Decreases in FPG ( 0.05 mmol/l , 0.6 % ) , HbA1c ( 0.5 % , 9.6 % ) and hs-CRP ( 2.7 ng/ml , 35.1 % ) concentrations in the resistant dextrin group were not significant when compared with the maltodextrin group . In conclusion , resistant dextrin supplementation can modulate inflammation and improve insulin resistance in women with type 2 diabetes Aims : This trial aims to determine the effects of resistant starch ( RS ) subtype 2 ( RS2 ) on glycemic status , metabolic endotoxemia and markers of oxidative stress . Methods : A r and omized , controlled , parallel-group clinical trial group of 56 females with type 2 diabetes mellitus ( T2DM ) was divided to 2 groups . The intervention group ( n = 28 ) and control group ( n = 28 ) received 10 g/day RS2 or placebo for 8 weeks , respectively . Fasting blood sample s were taken to determine glycemic status , endotoxin , high sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde ( MDA ) , total antioxidant capacity ( TAC ) , antioxidant enzymes concentrations as well as uric acid at baseline and after the intervention . Results : After 8 weeks , RS2 caused a significant decrease in the levels of MDA ( -34.10 % ) , glycosylated hemoglobin ( -9.40 % ) , insulin ( -29.36 % ) , homeostasis model of insulin resistance ( -32.85 % ) and endotoxin ( -25.00 % ) , a significant increase in TAC ( 18.10 % ) and glutathione peroxidase ( 11.60 % ) as compared with control . No significant changes were observed in fasting plasma glucose , quantitative insulin sensitivity check index , hs-CRP , superoxide dismutase , catalase and uric acid in the RS2 group as compared with the control group . Conclusion : Supplementation with RS2 may be improved glycemic status , endotoxemia and markers of oxidative stress in patients with T2DM OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Introduction Type 2 diabetes ( T2D ) has reached epidemic proportions in North America . Recent evidence suggests that prebiotics can modulate the gut microbiome , which then plays an important role in regulating lipid metabolism , blood glucose , and insulin sensitivity . As such , prebiotics are appealing potential therapeutic strategies for prediabetes and T2D . The key objectives of this study were to determine the tolerability as well as the glucose and insulin modulating ability of  MSPrebiotic ® digestion resistant starch ( DRS ) in healthy mid-age ( MID ) and elderly ( ELD ) adults . Material s and methods This was a prospect i ve , blinded , placebo-controlled study . Prediabetes and diabetes were among the exclusion factors . ELD ( > 70 years ) and MID ( 30–50 years ) Canadian adults were recruited and , after 2 weeks of consuming placebo , they were r and omized to consume 30 g of either MSPrebiotic ® or placebo per day for 12 weeks . In total , 42 ELD and 42 MID participants completed the study . Blood sample s were collected over the 14-week study and analyzed for glucose , lipid profile , and CRP , lipid particles , TNF-α , IL-10 , insulin , and insulin resistance ( IR ) . Results At baseline , the ELD population had a significantly higher percentage ( p < 0.01 ) with elevated glucose and significantly higher TNF-α ( p < 0.01 ) compared to MID adults .  MSPrebiotic ® DRS was well tolerated in both MID and ELD adults . There was a significant difference over time in blood glucose ( p = 0.0301 ) and insulin levels ( p = 0.009 ) , as well as IR ( HOMA-IR ; p = 0.009 ) in ELD adults who consumed MSPrebiotic ® compared to placebo . No significant changes were found in MID adults . Conclusion Our results suggest that dietary supplementation with prebiotics such as MSPrebiotic ® may be part of an effective strategy to reduce IR , a major risk factor for developing T2D , in the ELD . Clinical Trial Registration NCT01977183 listed on NIH website : Clinical Trials.gov , The meta data generated in this study have been su bmi tted to the NCBI Sequence Read Archive ( http://www.ncbi.nlm.nih.gov/bioproject/381931 ) The objective of the present study was to determine the effectiveness of a soluble dietary fiber , NUTRIOSE ® , on body weight , body composition , energy intake and hunger  in overweight Chinese men . The volunteers were r and omized in double-blind fashion to 250 ml fruit juice supplemented with NUTRIOSE ® ( Test , n = 60 ) or a maltodextrin ( Control , n = 60 ) at a dosage of 17 g twice daily for 12 weeks . Body weight , body composition were performed at 0 , 4 , 8 and 12 weeks while daily energy intake and hunger were assessed every 3 days . Test subjects had reductions in body weight ( 1.5 kg , P < 0.001 ) , body mass index ( 0.5 kg/m2 , P < 0.001 ) and body fat percentage ( 0.3 % , P < 0.001 ) versus Controls . NUTRIOSE ® supplementation result ed in a lower daily energy intake ( 3,079 kJ/day , P < 0.001 ) with group differences noted as early as 3 days . Test subjects reported less hunger across the study period versus Controls ( P < 0.01 ) . NUTRIOSE ® supplementation for 12 weeks results in body composition improvements and reduces body weight , energy intake and hunger in overweight men OBJECTIVE The aim of the present study was to determine effects of Resistant Starch ( RS2 ) on metabolic parameters and inflammation in women with type 2 diabetes ( T2DM ) . METHODS In this r and omized controlled clinical trial , 60 females with T2DM were divided into intervention ( n = 28 ) and placebo groups ( n = 32 ) . They received 10 g/d RS2 or placebo for 8 weeks , respectively . Fasting blood sugar ( FBS ) , glycated hemoglobin ( HbA1c ) , lipid profile , high-sensitive C-reactive protein ( hs-CRP ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-α ) were measured at baseline and at the end of the trial . Paired t test , unpaired t-test and ANCOVA were used to compare the quantitative variables . The data were analyzed using SPSS software version 13.0 . RESULTS RS2  decreased HbA1c ( -0.3 % , -3.6 % ) , TNF-α ( -3.4 pg/mL , -18.9 % ) , triglyceride ( -33.4 mg/dL , -15.4 % ) , and it increased HDL-c ( + 9.4 mg/dL , + 24.6 % ) significantly compared with the placebo group ( p < 0.05 ) . Changes in FBS , total cholesterol , low-density lipoprotein , hs-CRP and IL-6 were not significant in the RS2 group compared with the control group . RS2 can improve glycemic status , inflammatory markers and lipid profile in women with T2DM . CONCLUSIONS Although findings of the present study indicated positive effects of RS2  on inflammation and metabolic parameters , more studies are needed to confirm efficacy of RS2 as an adjunct therapy in diabetes INTRODUCTION Many of the deleterious effects associated with chronic kidney disease ( CKD ) are secondary to the result ant systemic inflammation . The gut microbial changes caused by CKD are thought to perpetuate systemic inflammation . Therefore , strategies aim ed at modulating the gut microbiota may be helpful in reducing complications associated with CKD . We hypothesized that supplementation with high-amylose maize resistant starch type 2 ( HAM-RS2 ) would beneficially alter the gut microbiome and lead to lower levels of systemic inflammation . METHODS A double-blind , parallel , r and omized , placebo-controlled trial was performed comparing dietary supplementation of HAM-RS2 with placebo in patients with end-stage CKD .  Fecal microbial data were obtained from a subset of patients after DNA extraction and 16s sequencing . FINDINGS Supplementation of HAM-RS2 led to a decrease in serum urea , IL-6 , TNFα , and malondialdehyde ( P < 0.05 ) . The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation ( HAM-RS2-Day 0 : 0.40 ± 0.50 vs. HAM-RS2-Day 56 : 3.21 ± 4.97 P = 0.03 ) and was unchanged by placebo ( Control-Day 0 : 0.72 ± 0.72 vs. Control-Day 56 : 0.83 ± 1.57 P = 0.5 ) . DISCUSSION Supplementation of amylose resistant starch , HAM-RS2 , in patients with CKD led to an elevation in Faecalibacterium and decrease in systemic inflammation . Microbial manipulation in CKD patients by using the prebiotic fiber may exert an anti-inflammatory effect through an elevation in the bacterial genera Faecalibacterium OBJECTIVE The objective of this study is to explore the effect of high-resistant starch ( RS ) , low-protein flour as a source of RS on patients with early type 2 diabetic nephropathy ( DN ) through the clinical intervention trial . DESIGN This was a single center , r and omized , comparative , open-label trial . Seventy-five patients with early DN , aged 18 to 80 y , were recruited and r and omly assigned to two groups . During the 12-week intervention , the control group patients ( 38 cases ) followed protein-restriction diet daily with a common staple . The intervention group ( 37 cases ) received 50 g of high-RS , low-protein flour instead of a common staple of equal quality at lunch and dinner each day . The blood glucose , blood lipids , nutritional parameters , indicators of renal function , oxidative stress , and inflammatory markers were measured . RESULTS Compared with the control group , high-RS , low-protein flour intake led to a significant reduction in fasting blood glucose , HbA1c , total cholesterol , and triglycerides levels ( P < .05 for all ) . The changes in serum uric acid ( UA ) and β2-microglobulin ( β2-MG ) level were observed after high-RS , low-protein flour intervention ( uric acid [ mean ± st and ard deviation ] : -24.7 ± 38.5 μmol/L , P = .001 ; β2-MG : 0.5 ± 0.9 mg/L , P = 0.018 ) . In addition , high-RS , low-protein flour intake increased serum superoxide dismutase level by 10.1 ± 27.7 U/mL ( P < .05 ) ; however , it did not change the interleukin-6 and Tumor Necrosis Factor α ( TNF-α ) concentration . CONCLUSIONS Twelve-week intervention with high-RS , low-protein flour improved the blood glucose and blood lipid levels , decreased the serum uric acid ( UA ) and urine β2-MG , and enhanced the ability to prevent antioxidative stress in patients with early DN
target: Moreover , the changes in interleukin 6 concentration was dependent on study quality and intervention duration .
  The current meta- analysis indicated that RS intake can improve some inflammatory biomarkers .
background: This study aim ed to summarize earlier studies on the effects of  RS consumption on the serum levels of inflammatory biomarkers .