Whey Protein, Resistance Training, and Changes in Body Composition

November 7, 2012 updated by: Richard Washburn, University of Kansas

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.

Study Overview

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

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Energy Balance Lab, The University of Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Whey protein supplementation
Daily whey protein supplementation
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
40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)
EXPERIMENTAL: Placebo
Daily carbohydrate placebo supplementation
40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months
Muscular strength and endurance
Time Frame: 9 months
One rep max strength will be measured on the chest and leg press.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Richard A. Washburn, Ph.D., University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (ESTIMATE)

August 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HSCL16583
  • DMI01425 (OTHER_GRANT: Dairy Management Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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