## Protocol Section
### Identification Module
**NCT ID:** NCT00739479

**Brief Title:** CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)

**Official Title:** CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)

#### Organization Study ID Info
**ID:** 200816190-1
#### Organization
**Class:** OTHER
**Full Name:** University of California, Davis
### Status Module
#### Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-10-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Start Date
**Date:** 2008-08

**Status Verified Date:** 2008-08

#### Study First Post Date
**Date:** 2008-08-21
**Type:** ESTIMATED
**Study First Submit Date:** 2008-08-19
**Study First Submit QC Date:** 2008-08-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** California Dairy Research Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Sidika E. Karakas, MD

#### Responsible Party

**Investigator Affiliation:** University of California, Davis

**Investigator Full Name:** Sidika E. Karakas, MD

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to compare the effects of two different protein supplements (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight loss in obse individuals with metabolic syndrome (METS). These two supplements will contain equal amounts of protein but differ considerably in their amino acid contents. Whey protein is rich in essential amino acids whereas gelatin is rich in proline.

In obese individuals with METS, the hypotheses are:

* PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.
* PHWP will improve insulin action more than PHG.
* PHWP will decrease cardiovascular disease risk more than PHG.

**Detailed Description:** The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems: Obesity, especially located in the waist area, elevated blood fats (lipids), high blood pressure and insulin resistance. The METS affects one third of the adult population in the USA and increases the risks for both diabetes and hardening of the arteries, leading to heart attacks and strokes.

The best treatment for improving the symptoms of METS is weight loss. In previous studies, it has been demonstrated that whey protein (WP) supplementation increased weight loss and especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We now propose to compare WP to another protein source in patients with the METS during weight loss. In addition, we will use a special preparation called partially hydrolyzed whey protein, which may have specific properties that increase fat mass loss.

### Conditions Module

**Conditions:**

- Metabolic Syndrome

- Overweight

**Keywords:**

- Metabolic Syndrome

- METS

- Obesity

- Partially Hydrolyzed Whey Protein

- Partially Hydrolyzed Gelatin

- PHWP

- PHG

- Weight Loss

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.

**Intervention Names:**

- Dietary Supplement: Weight Loss

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.

**Intervention Names:**

- Dietary Supplement: Weight Loss

**Label:** 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** Participants will reduce their total dietary intake by \~800 kcal/day. \~100 kcal will be replaced by either the PHWP of PHG protein supplement, resulting in a total energy restriction of \~700 kcal/day.

**Name:** Weight Loss

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.

**Time Frame:** 2 Years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following)

  * Waist Circumference: men: \>40 in women: \>35 in
  * Blood Pressure: \>135/\>85 mm Hg
  * Triglycerides: \>150 mg/dl
  * HDL-cholesterol: men: \<40 mg/dl women: \<50 mg/dl
  * Fasting Glucose: \>100 mg/dl
* Ages 18 to 65 Years
* BMI range of 27 to 42 kg/m\^2
* Body weight \<300 lbs
* Weight Stable for 3 Months

Exclusion Criteria:

* Subjects who habitually consume protein supplements or have eating disorders
* Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant
* Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes
* Triglyceride \>500 mg/dl, Cholesterol \>260 mg/dl
* Use of insulin sensitizers, lipid lowering medication or ACE inhibitors
* Use of anti-obesity medications or supplements for at lease 6 months prior to start of study
* Known allergy or adverse reaction to protein and dairy products (including lactose)

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sacramento

**Country:** United States

**Facility:** UC Davis CCRC

**State:** California

**Zip:** 95616

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Davis

**Name:** Sidika E Kasim-Karakas, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Piccolo BD, Comerford KB, Karakas SE, Knotts TA, Fiehn O, Adams SH. Whey protein supplementation does not alter plasma branched-chained amino acid profiles but results in unique metabolomics patterns in obese women enrolled in an 8-week weight loss trial. J Nutr. 2015 Apr;145(4):691-700. doi: 10.3945/jn.114.203943. Epub 2015 Feb 4.

**PMID:** 25833773

**Citation:** Comerford KB, Buchan W, Karakas SE. The effects of weight loss on FABP4 and RBP4 in obese women with metabolic syndrome. Horm Metab Res. 2014 Mar;46(3):224-31. doi: 10.1055/s-0033-1353204. Epub 2013 Aug 26.

**PMID:** 23979787

#### See Also Links

**Label:** UC Davis Website - Featured Clinical Trials

**URL:** http://www.ucdmc.ucdavis.edu/clinicaltrials/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

- ID: D000024821

- Term: Metabolic Syndrome

- ID: D000013577

- Term: Syndrome

- ID: D000015431

- Term: Weight Loss

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T435

- Name: Whey Protein

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
