Whey Protein, Resistance Training, and Changes in Body Composition

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Richard Washburn, University of Kansas
ClinicalTrials.gov Identifier:
NCT01186536
First received: March 26, 2010
Last updated: November 7, 2012
Last verified: November 2012

March 26, 2010
November 7, 2012
June 2007
July 2012   (final data collection date for primary outcome measure)
Body Composition [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
Same as current
Complete list of historical versions of study NCT01186536 on ClinicalTrials.gov Archive Site
  • 24 hour energy expenditure and substrate oxidation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    24hr energy expenditure and substrate oxidation will be measured by whole room indirect calorimetry
  • Muscular strength and endurance [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    One rep max strength will be measured on the chest and leg press.
  • Resting Metabolic Rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Resting metabolic rate as measured by indirect calorimetry as kcal/day will be evaluated. Also, substrate oxidation (fat and carbohydrate oxidation) will be evaluated.
Same as current
Not Provided
Not Provided
 
Whey Protein, Resistance Training, and Changes in Body Composition
Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186536
HSCL16583, DMI01425
Yes
Richard Washburn, University of Kansas
University of Kansas
Dairy Management Inc.
Principal Investigator: Richard A. Washburn, Ph.D. University of Kansas
University of Kansas
November 2012

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