Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
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| ClinicalTrials.gov Identifier: NCT01358305 |
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Recruitment Status :
Completed
First Posted : May 23, 2011
Last Update Posted : October 7, 2019
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Sponsor:
DuPont Nutrition and Health
Collaborator:
University of Texas
Information provided by (Responsible Party):
DuPont Nutrition and Health
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | May 19, 2011 | |||||||||
| First Posted Date ICMJE | May 23, 2011 | |||||||||
| Last Update Posted Date | October 7, 2019 | |||||||||
| Study Start Date ICMJE | January 2011 | |||||||||
| Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Muscle Protein Synthesis or Fractional synthesis rate (FSR) [ Time Frame: baseline, 3 hours, 5 hours ] The fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of L-[ring-13C6]Phenylalanine into the mixed muscle proteins, and the free-tissue phenylalanine enrichment.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Protein Blends (Soy, Whey and Casein) for Muscle Synthesis | |||||||||
| Official Title ICMJE | A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown | |||||||||
| Brief Summary | Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs. Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow). This intermediate rate may allow soy protein to have an extended window of muscle protein synthesis that has not been monitored in previous studies. While most of the sports nutrition "recovery" products are dairy-based protein blends (high in branched-chain amino acids), soy protein offers additional benefits that can make an important contribution to these types of sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more glutamine compared to whey protein and these two amino acids may bring additional benefits (immunity and hydration, respectively) to athletes. A "blend" of high-quality proteins (soy and dairy) may be the optimal sports nutrition product for athletes to consume following training. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Muscle Synthesis | |||||||||
| Intervention ICMJE | Other: Protein Blend
Single intake of approximately 20 grams of total protein
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| Study Arms ICMJE |
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| Publications * | Reidy PT, Walker DK, Dickinson JM, Gundermann DM, Drummond MJ, Timmerman KL, Fry CS, Borack MS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Protein blend ingestion following resistance exercise promotes human muscle protein synthesis. J Nutr. 2013 Apr;143(4):410-6. doi: 10.3945/jn.112.168021. Epub 2013 Jan 23. | |||||||||
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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 | |||||||||
| Actual Enrollment ICMJE |
19 | |||||||||
| Original Estimated Enrollment ICMJE |
20 | |||||||||
| Actual Study Completion Date ICMJE | March 2013 | |||||||||
| Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion criteria will be:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 35 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01358305 | |||||||||
| Other Study ID Numbers ICMJE | CRC-D-176 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | DuPont Nutrition and Health | |||||||||
| Original Responsible Party | Ratna Mukherjea, Solae, LLC | |||||||||
| Current Study Sponsor ICMJE | DuPont Nutrition and Health | |||||||||
| Original Study Sponsor ICMJE | Solae, LLC | |||||||||
| Collaborators ICMJE | University of Texas | |||||||||
| Investigators ICMJE |
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| PRS Account | DuPont Nutrition and Health | |||||||||
| Verification Date | October 2019 | |||||||||
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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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