Muscle Synthesis Clinical Trial
Official title:
A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown in Healthy Older Adults
| NCT number | NCT01847261 |
| Other study ID # | IRB #12-226 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | December 2014 |
| Verified date | October 2019 |
| Source | DuPont Nutrition and Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
During aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility. Protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training. This study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 55 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 55-70 yr olds Stable Body weight Exclusion Criteria: 1. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise) 2. Significant heart, liver, kidney, blood, respiratory disease or thyroid issues 3. Peripheral vascular disease 4. Orthopedic injury that prohibits participation in the exercise training 5. Diabetes mellitus or other untreated endocrine disease 6. Active cancer (all groups) and history of cancer 7. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes) 8. Neurologic Injury or disease 9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids. 10. Alcohol or drug abuse 11. Tobacco use (smoking or chewing) 12. Malnutrition (BMI < 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia) 13. Obesity (BMI > 30 kg/m2) 14. Low hemoglobin levels (below normal values) 15. Food allergies 16. Taking dietary supplements such as green tea, omega 3 fatty acids, etc. 17. Females |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Texas Medical Branch | Galveston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| DuPont Nutrition and Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fractional Synthetic Rate (Muscle Protein Synthesis) | 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 hrs, 5 hrs | |
| Secondary | Anti-inflammatory and Anti-oxidant Markers | Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx). | baseline, 3 hrs, 5 hrs | |
| Secondary | Intracellular Signalling Genes and Proteins | Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques | baseline, 3 hrs, 5 hrs |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01317511 -
Protein Supply in Elderly
|
N/A | |
| Completed |
NCT01358305 -
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
|
N/A |