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Protein Blends (Soy, Whey and Casein) for Muscle Synthesis

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ClinicalTrials.gov Identifier: NCT01358305
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
DuPont Nutrition and Health

Tracking Information
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
 (submitted: May 20, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • oxidative and inflammatory markers [ Time Frame: baseline, 3 hours, 5 hours ]
    Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx).
  • Phosphorylation of protein in muscle protein signaling pathways [ Time Frame: baseline, 3 hours, 5 hours ]
    Phosphorylation of mTOR, 4E-BP1, S6K1, S6, and eEF2 will be measured using Western blot techniques as previously described.
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
Condition  ICMJE Muscle Synthesis
Intervention  ICMJE Other: Protein Blend
Single intake of approximately 20 grams of total protein
Study Arms  ICMJE
  • Active Comparator: Whey Protein Isolate
    Intervention: Other: Protein Blend
  • Experimental: Protein Blend (soy, whey and casein)
    Intervention: Other: Protein Blend
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
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:

  1. Age 18-35 yrs
  2. Stable body weight for at least 1 year

Exclusion criteria will be:

  1. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  2. Significant heart, liver, kidney, blood, or respiratory disease
  3. Peripheral vascular disease
  4. Diabetes mellitus or other untreated endocrine disease
  5. Active cancer (all groups) and history of cancer (groups potentially randomizable to rapamycin)
  6. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
  7. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
  8. Alcohol or drug abuse
  9. Tobacco use (smoking or chewing)
  10. Malnutrition (BMI < 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
  11. Obesity (BMI > 30 kg/m2)
  12. Low hemoglobin levels (below normal values)
  13. Food allergies
  14. Taking dietary supplements such as green tea, etc.
  15. Currently on a high-soy diet (consuming >2 servings of soy per day)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Ratna Mukherjea, PhD Solae, LLC
Principal Investigator: Mark B Cope, PhD Solae, LLC
Principal Investigator: Blake B Rasmussen, PhD UTMB
PRS Account DuPont Nutrition and Health
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP