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

This study has been completed.
Sponsor:
Collaborator:
California Dairy Research Foundation
Information provided by (Responsible Party):
Sidika E. Karakas, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00739479
First received: August 19, 2008
Last updated: October 25, 2012
Last verified: August 2008
  Purpose

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.

Condition Intervention
Metabolic Syndrome
Overweight
Dietary Supplement: Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00739479

Locations
United States, California
UC Davis CCRC
Sacramento, California, United States, 95616
Sponsors and Collaborators
Sidika E. Karakas, MD
California Dairy Research Foundation
Investigators
Principal Investigator: Sidika E Kasim-Karakas, MD University of California, Davis
  More Information

Additional Information:
No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidika E. Karakas, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00739479     History of Changes
Other Study ID Numbers: 200816190-1
Study First Received: August 19, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Metabolic Syndrome
METS
Obesity
Partially Hydrolyzed Whey Protein
Partially Hydrolyzed Gelatin
PHWP
PHG
Weight Loss

Additional relevant MeSH terms:
Weight Loss
Overweight
Metabolic Syndrome X
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014