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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01358305
First received: May 19, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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 Intervention
Muscle Synthesis
Other: Protein Blend

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown

Resource links provided by NLM:


Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • Muscle Protein Synthesis or Fractional synthesis rate (FSR) [ Time Frame: baseline, 3 hours, 5 hours ] [ Designated as safety issue: No ]
    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:
  • oxidative and inflammatory markers [ Time Frame: baseline, 3 hours, 5 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Phosphorylation of mTOR, 4E-BP1, S6K1, S6, and eEF2 will be measured using Western blot techniques as previously described.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Solae, LLC

Additional 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
Study First Received: May 19, 2011
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014