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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 : December 5, 2014
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Solae, LLC

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.

Condition or disease Intervention/treatment Phase
Muscle Synthesis Other: Protein Blend Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown
Study Start Date : January 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Casein
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Whey Protein Isolate Other: Protein Blend
Single intake of approximately 20 grams of total protein
Experimental: Protein Blend (soy, whey and casein) Other: Protein Blend
Single intake of approximately 20 grams of total protein



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358305


Locations
United States, Texas
UTMB General Clinical Research Center, located in the John Sealy Hospital
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Solae, LLC
University of Texas
Investigators
Principal Investigator: Ratna Mukherjea, PhD Solae, LLC
Principal Investigator: Mark B Cope, PhD Solae, LLC
Principal Investigator: Blake B Rasmussen, PhD UTMB

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01358305     History of Changes
Other Study ID Numbers: CRC-D-176
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by Solae, LLC:
muscle
synthesis
mTOR
antioxidant
inflammatory markers
soy protein
whey
casein

Additional relevant MeSH terms:
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action