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

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis CCRC

Sacramento, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Weight loss

Dietary Supplement

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.

Primary outcomes

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

Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Sidika E. Karakas, MD

Other

Collaborators

California Dairy Research Foundation

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Aug 21, 2008
Registry last updated: Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed