- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186536
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
Status
Completed
Conditions
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.
Sponsor
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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