Clinical trial NCT00739479: CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
Official title: CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Overweight
Keywords: Metabolic Syndrome
METS
Obesity
Partially Hydrolyzed Whey Protein
Partially Hydrolyzed Gelatin
PHWP
PHG
Weight Loss
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: California Dairy Research Foundation
First posted: 2008-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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)

Primary outcomes:
measure: The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis CCRC
state: California
Study officials:
affiliation: University of California, Davis
name: Sidika E Kasim-Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piccolo BD, Comerford KB, Karakas SE, Knotts TA, Fiehn O, Adams SH. Whey protein supplementation does not alter plasma branched-chained amino acid profiles but results in unique metabolomics patterns in obese women enrolled in an 8-week weight loss trial. J Nutr. 2015 Apr;145(4):691-700. doi: 10.3945/jn.114.203943. Epub 2015 Feb 4.
citation: Comerford KB, Buchan W, Karakas SE. The effects of weight loss on FABP4 and RBP4 in obese women with metabolic syndrome. Horm Metab Res. 2014 Mar;46(3):224-31. doi: 10.1055/s-0033-1353204. Epub 2013 Aug 26.