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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739479
• Other study ID #: 200816190-1
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: October 25, 2012
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2008
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight
• Syndrome
• Weight Loss

Intervention

Dietary Supplement:
• Weight Loss
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.

Locations

Country	Name	City	State
United States	UC Davis CCRC	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Sidika E. Karakas, MD	California Dairy Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.		2 Years	No

External Links

•   UC Davis Website - Featured Clinical Trials