Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men (NDC)
| Tracking Information | |||||
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| First Received Date ICMJE | February 3, 2010 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Muscle protein synthesis, whole body amino acid oxidation [ Time Frame: Acute within the day ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01062711 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
muscle protein breakdown, serum insulin, plasma amino acid concentrations [ Time Frame: Acute within the day ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men | ||||
| Official Title ICMJE | Responses of Muscle and Whole-body Protein Turnover to Ingestion of Differing Doses of Whey and Soy Protein With and Without Resistance Exercise in Elderly Men | ||||
| Brief Summary | When we age, we lose muscle. It is not exactly clear why this happens, but we do know that this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e. performing resistance exercise) and proper nutrition, in particular eating enough high quality protein, can help slow the loss of muscle mass or potentially even reverse it. Protein and resistance exercise are thought to do this by stimulating your muscle to make more proteins and/or potentially by slowing down the rate at which your body breaks proteins down. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. However, to date, the effect that whey protein has on muscle protein synthesis, particularly in the elderly has yet to be determined. Thus the purposes of this study are: 1) to determine if whey is an effective source of protein that will stimulate muscle protein synthesis in the elderly, similar to what we have previously seen in young persons; 2) to determine the smallest amount of whey protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if performing resistance exercise will augment the increase in new muscle protein synthesis with whey consumption; and 4) to try and found out if whey is more effective than soy protein in stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the elderly, similar to what we have previously seen in young persons |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Sarcopenia | ||||
| Intervention ICMJE | Dietary Supplement: Whey or soy protein
Whey and casein are isolated milk proteins |
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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 | ||||
| Estimated Enrollment ICMJE | 81 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 60 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01062711 | ||||
| Other Study ID Numbers ICMJE | DMI 1484 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stuart Phillips, Ph.D., Professor and Associate Chair, Graduate Studies, McMaster University, Department of Kinesiology | ||||
| Study Sponsor ICMJE | McMaster University | ||||
| Collaborators ICMJE | National Dairy Council | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | July 2011 | ||||
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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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