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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Whey Protein supplement
Dietary Supplement: Soy Protein Supplement
Dietary Supplement: Carbohydrate supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 85
Study Start Date: June 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whey protein supplementation
Daily whey protein supplementation
 Dietary Supplement: Whey Protein supplement
40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)
Experimental: Soy Protein supplementation
Daily soy protein supplementation
 Dietary Supplement: Soy Protein Supplement
40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)
Experimental: Placebo
Daily carbohydrate placebo supplementation
 Dietary Supplement: Carbohydrate supplement
40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186536

Locations
United States, Kansas
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Dairy Management Inc.
Investigators
Principal Investigator: Richard A. Washburn, Ph.D. University of Kansas
  More Information

No publications provided

Responsible Party: Richard Washburn, Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01186536     History of Changes
Other Study ID Numbers: HSCL16583, DMI01425
Study First Received: March 26, 2010
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Whey Protein
Soy Protein
Resistance training
Weight Management

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013