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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome, Overweight

Intervention / Treatment
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* Dietary Supplement: Weight Loss


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. | Dietary Supplement: Weight Loss<br>* 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.<br>|
| Placebo Comparator: 2<br>Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. | Dietary Supplement: Weight Loss<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS. |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, METS, Obesity, Partially Hydrolyzed Whey Protein, Partially Hydrolyzed Gelatin, PHWP, PHG, Weight Loss