Whey Protein, Resistance Training, and Changes in Body Composition
| Tracking Information | |||||
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| First Received Date ICMJE | March 26, 2010 | ||||
| Last Updated Date | November 7, 2012 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01186536 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Whey Protein, Resistance Training, and Changes in Body Composition | ||||
| Official Title ICMJE | Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults. | ||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 85 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 30 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01186536 | ||||
| Other Study ID Numbers ICMJE | HSCL16583, DMI01425 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Richard Washburn, University of Kansas | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | Dairy Management Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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