Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Whey Protein, Resistance Training, and Changes in Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01186536
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : November 9, 2012
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Richard Washburn, University of Kansas

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date November 9, 2012
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
Body Composition [ Time Frame: 9 months ]
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
  • 24 hour energy expenditure and substrate oxidation [ Time Frame: 9 months ]
    24hr energy expenditure and substrate oxidation will be measured by whole room indirect calorimetry
  • Muscular strength and endurance [ Time Frame: 9 months ]
    One rep max strength will be measured on the chest and leg press.
  • Resting Metabolic Rate [ Time Frame: 9 months ]
    Resting metabolic rate as measured by indirect calorimetry as kcal/day will be evaluated. Also, substrate oxidation (fat and carbohydrate oxidation) will be evaluated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whey Protein, Resistance Training, and Changes in Body Composition
Official Title  ICMJE Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.
Brief Summary The objective of this project is to determine the effect of 9 months of progressive resistance training with daily whey protein supplements on the body composition (changes in muscle and fat) in young adults. The investigators hypothesize that those individuals who receive whey protein supplements will have larger gains in muscle and larger losses of fat tissue in response to resistance training compared to those who receive supplements of soy or carbohydrate.
Detailed Description Healthy men and women will be recruited to participate in 9 months of supervised resistance training (3 days/wk) and will be randomized to one of three daily supplement groups: Whey protein, soy protein, or carbohydrate control. Body weight, muscular strength and endurance, and resting blood pressure will be assessed at baseline, 3, 6 and 9 months. Body composition will be assessed at baseline, 3, 5, 7, and 9 months. A sub-sample (N = 17 per group, assessed at baseline and 9 months) will be randomly selected for muscle samples of the upper leg to determine changes in the size of muscle fibers, and chemical factors associated with muscle growth. Blood samples will be obtained from sub-sample participants to assess changes in glucose and fat metabolism, as well as other chemicals likely to promote or inhibit muscle growth. We will also assess changes in daily energy expenditure and the use of fuel to produce energy (carbohydrate, fat, protein) that may result from the intervention. We hypothesize that those individuals who receive whey protein supplements will have larger gains in muscle and larger losses of fat tissue in response to resistance training compared to those who receive supplements of soy or carbohydrate.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Whey Protein supplement
    40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)
  • Dietary Supplement: Soy Protein Supplement
    40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)
  • Dietary Supplement: Carbohydrate supplement
    40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)
Study Arms  ICMJE
  • Experimental: Whey protein supplementation
    Daily whey protein supplementation
    Intervention: Dietary Supplement: Whey Protein supplement
  • Experimental: Soy Protein supplementation
    Daily soy protein supplementation
    Intervention: Dietary Supplement: Soy Protein Supplement
  • Experimental: Placebo
    Daily carbohydrate placebo supplementation
    Intervention: Dietary Supplement: Carbohydrate supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
85
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2010)
120
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 25-39.9
  • must be 18- 30 years old
  • sedentary
  • no medications
  • stable weight for at least 3 months

Exclusion Criteria:

  • Tobacco/Drug user
  • metabolism altering medication
  • gain/lost 10lbs in the last 3 months
  • current exerciser
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01186536
Other Study ID Numbers  ICMJE HSCL16583
DMI01425 ( Other Grant/Funding Number: Dairy Management Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Washburn, University of Kansas
Study Sponsor  ICMJE University of Kansas
Collaborators  ICMJE Dairy Management Inc.
Investigators  ICMJE
Principal Investigator: Richard A. Washburn, Ph.D. University of Kansas
PRS Account University of Kansas
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP