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Mather, California


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Clinical Diagnoses of Metabolic Syndrome - Ages 18 to 60 Years - BMI range of 27 to 37 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)


NCT ID:

NCT00739479


Primary Contact:

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

Rebekka K Zak, BS
Phone: (916) 703-5481
Email: rebekka.zak@gmail.com


Backup Contact:

Email: mlvargas@ucdavis.edu
Luisa M Vargas, CCRP
Phone: (916) 703-5480


Location Contact:

Mather, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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