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

Primary Purpose

Metabolic Syndrome, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Sponsored by
Sidika E. Karakas, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, METS, Obesity, Partially Hydrolyzed Whey Protein, Partially Hydrolyzed Gelatin, PHWP, PHG, Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • UC Davis CCRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm 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.

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

Outcomes

Primary Outcome Measures

The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2008
Last Updated
October 25, 2012
Sponsor
Sidika E. Karakas, MD
Collaborators
California Dairy Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00739479
Brief Title
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sidika E. Karakas, MD
Collaborators
California Dairy Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Overweight
Keywords
Metabolic Syndrome, METS, Obesity, Partially Hydrolyzed Whey Protein, Partially Hydrolyzed Gelatin, PHWP, PHG, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm 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.
Arm Title
2
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Weight Loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika E Kasim-Karakas, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis CCRC
City
Sacramento
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25833773
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.
Results Reference
derived
PubMed Identifier
23979787
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.
Results Reference
derived
Links:
URL
http://www.ucdmc.ucdavis.edu/clinicaltrials/
Description
UC Davis Website - Featured Clinical Trials

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

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