Muscle Synthesis Clinical Trial
Official title:
A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown
| NCT number | NCT01358305 |
| Other study ID # | CRC-D-176 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2011 |
| Est. completion date | March 2013 |
| Verified date | October 2019 |
| Source | DuPont Nutrition and Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | March 2013 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | UTMB General Clinical Research Center, located in the John Sealy Hospital | Galveston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| DuPont Nutrition and Health | University of Texas |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Muscle Protein Synthesis or Fractional synthesis rate (FSR) | 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. | baseline, 3 hours, 5 hours | |
| Secondary | oxidative and inflammatory markers | Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx). | baseline, 3 hours, 5 hours | |
| Secondary | Phosphorylation of protein in muscle protein signaling pathways | Phosphorylation of mTOR, 4E-BP1, S6K1, S6, and eEF2 will be measured using Western blot techniques as previously described. | baseline, 3 hours, 5 hours |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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