CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
NCT ID: NCT00739479
Last Updated: 2012-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2008-08-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California Dairy Research Foundation
OTHER
Sidika E. Karakas, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sidika E. Karakas, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sidika E Kasim-Karakas, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Davis CCRC
Sacramento, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
UC Davis Website - Featured Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200816190-1
Identifier Type: -
Identifier Source: org_study_id