Whey Protein, Resistance Training, and Changes in Body Composition

NCT ID: NCT01186536

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Whey Protein Soy Protein Resistance training Weight Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Whey protein supplementation

Daily whey protein supplementation

Group Type EXPERIMENTAL

Whey Protein supplement

Intervention Type DIETARY_SUPPLEMENT

40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)

Soy Protein supplementation

Daily soy protein supplementation

Group Type EXPERIMENTAL

Soy Protein Supplement

Intervention Type DIETARY_SUPPLEMENT

40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)

Placebo

Daily carbohydrate placebo supplementation

Group Type EXPERIMENTAL

Carbohydrate supplement

Intervention Type DIETARY_SUPPLEMENT

40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)

Interventions

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Whey Protein supplement

40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)

Intervention Type DIETARY_SUPPLEMENT

Soy Protein Supplement

40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate supplement

40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Richard Washburn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard A. Washburn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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Energy Balance Lab, The University of Kansas

Lawrence, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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DMI01425

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSCL16583

Identifier Type: -

Identifier Source: org_study_id