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Sponsors and Collaborators: |
University of California, Davis California Dairy Research Foundation |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00739479 |
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:
Condition | Intervention |
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Metabolic Syndrome Overweight |
Dietary Supplement: Weight Loss |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS) |
Estimated Enrollment: | 80 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.
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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.
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2: Placebo Comparator
Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.
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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.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebekka K Zak, BS | (916) 703-5481 | rebekka.zak@gmail.com |
Contact: Luisa M Vargas, CCRP | (916) 703-5480 | mlvargas@ucdavis.edu |
United States, California | |
Clinical and Translational Science Center Clinical Research Center | |
Mather, California, United States |
Principal Investigator: | Sidika E Kasim-Karakas, MD | University of California, Davis |
Responsible Party: | UC Davis ( Sidika Kasim-Karakas ) |
Study ID Numbers: | 200816190-1 |
Study First Received: | August 19, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00739479 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metabolic Syndrome METS Obesity Partially Hydrolyzed Whey Protein |
Partially Hydrolyzed Gelatin PHWP PHG Weight Loss |
Body Weight Signs and Symptoms Obesity Whey Protein |
Weight Loss Body Weight Changes Overweight |
Body Weight Signs and Symptoms Pathologic Processes Disease |
Syndrome Weight Loss Body Weight Changes Overweight |