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

October 25, 2012 updated by: Sidika E. Karakas, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95616
        • UC Davis CCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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
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.
Placebo Comparator: 2
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidika E. Karakas, MD

Collaborators

California Dairy Research Foundation

Investigators

  • Principal Investigator: Sidika E Kasim-Karakas, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200816190-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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