NCT00739479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 29, 2012

Status Verified

August 1, 2008

Enrollment Period

2 years

First QC Date

August 19, 2008

Last Update Submit

October 25, 2012

Conditions

Metabolic SyndromeOverweight

Keywords

Metabolic SyndromeMETSObesityPartially Hydrolyzed Whey ProteinPartially Hydrolyzed GelatinPHWPPHGWeight Loss

Outcome Measures

Primary Outcomes (1)

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

    2 Years

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

Weight LossDIETARY_SUPPLEMENT

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.

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis CCRC

Sacramento, California, 95616, United States

Location

Related Publications (2)

  • 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.

    PMID: 25833773DERIVED

  • 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.

    PMID: 23979787DERIVED

Related Links

MeSH Terms

Conditions

Metabolic SyndromeOverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Sidika E Kasim-Karakas, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 29, 2012

Record last verified: 2008-08

Locations

US(1)