CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
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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) |
- 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 |
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| United States, California | |
| UC Davis CCRC | |
| Sacramento, California, United States, 95616 | |
| Principal Investigator: | Sidika E Kasim-Karakas, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| 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 May 23, 2013