CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS) - NCT00739479- (Clinical Trial 238373)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy238373.aspx
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| City: |
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Mather |
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State:
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CA |
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| Conditions: |
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Metabolic Syndrome - Overweight |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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) |
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| Study is available at: |
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Clinical and Translational Science Center Clinical Research Center Mather, CA United States
Primary Contact: Rebekka K Zak, BS Email: rebekka.zak@gmail.com Phone: (916) 703-5481 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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