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

Sidika E. Karakas, MD

Status: Completed

Conditions: Overweight; Metabolic Syndrome

Treatments: Dietary Supplement: Weight Loss

Study type: Interventional

Funder types: Other

Identifiers

NCT00739479

200816190-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.

Treatment:

Dietary Supplement: Weight Loss

2

Placebo Comparator group

Description:

Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables.

Treatment:

Dietary Supplement: Weight Loss