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Completed

NCT Number: NCT01186536

Whey Protein, Resistance Training, and Changes in Body Composition

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein Supplement

Dietary Supplement

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

Soy Protein Supplement

Dietary Supplement

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

Carbohydrate supplement

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Muscular strength and endurance

    Time frame: 9 months

    One rep max strength will be measured on the chest and leg press.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 23, 2010
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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