Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
108 participants
INTERVENTIONAL
2009-03-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Inactivity is another likely contributor to sarcopenia. Exercise increases not only muscle protein synthesis,mass and strength, but also energy expenditure. Hence, exercise may improve the response of muscle to nutritional interventions in older subjects via increased energy requirements and food consumption, thereby allowing for achievement of true supplementation.
We will test the following specific hypotheses in older, community indwelling, sedentary subjects:
Using a factorial design we will address in older, community-indwelling, sedentary subjects the following hypotheses:
1. Nutritional supplementation with amino acids will improve muscle mass, strength, function, quality, and protein synthesis.
2. Progressive exercise training for 24 weeks will improve muscle mass strength,function, quality, perfusion, and protein metabolism.
3. Combined treatment with nutritional supplementation and progressive exercise training for 24 weeks will improve muscle mass, strength, function, quality, perfusion, and protein metabolism more than either intervention alone.
Our goal is to establish if specific interventions that can acutely increase muscle protein synthesis can also effectively translate into increased muscle mass and/or performance in older sedentary people, thus preventing frailty and promoting physical independence. To this end we will use stable isotope methodologies to measure muscle protein metabolism and contrast enhanced ultrasound to measure muscle perfusion, in order to determine if the treatments' acute effects can predict their chronic impact on muscle mass and function. We will also determine if chronic treatment leads to metabolic and/or vascular adaptations that may explain the measured changes in muscle mass and function.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nutritional supplement
Amino acids
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
Placebo + Exercise
Exercise
progressive exercise training
Nutritional Supplement + Exercise
Amino acids
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
Exercise
progressive exercise training
Placebo
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amino acids
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
Exercise
progressive exercise training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ability to sign consent form (score \>25 on the 30 item Mini Mental State Examination, MMSE)
3. stable body weight for at least 1 year (verified via medical records).
Exclusion Criteria
2. exercise training (≥2 weekly sessions of moderate-to-high intensity aerobic or resistance exercise)
3. significant heart, liver, kidney, blood or respiratory disease
4. peripheral vascular disease
5. diabetes or other untreated endocrine disease
6. active cancer
7. recent (within 6 months) treatment with anabolic steroids, or corticosteroids
8. alcohol or drug abuse
9. tobacco use (smoking or chewing, verified via medical records)
10. depression (\>5 on the 15-item Geriatric Depression Scale (GDS))
11. malnutrition (BMI \<20 kg/m2; hypoalbuminemia or hypotransferrenemia; protein intake\<0.66 g/kg/day at run-in)
12. obesity (BMI\>30 kg/m2).
65 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elena Volpi, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Medical Branch, Galveston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sealy Center on Aging, University of Texas Medical Branch
Galveston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Randolph AC, Markofski MM, Rasmussen BB, Volpi E. Effect of essential amino acid supplementation and aerobic exercise on insulin sensitivity in healthy older adults: A randomized clinical trial. Clin Nutr. 2020 May;39(5):1371-1378. doi: 10.1016/j.clnu.2019.06.017. Epub 2019 Jun 28.
Markofski MM, Jennings K, Timmerman KL, Dickinson JM, Fry CS, Borack MS, Reidy PT, Deer RR, Randolph A, Rasmussen BB, Volpi E. Effect of Aerobic Exercise Training and Essential Amino Acid Supplementation for 24 Weeks on Physical Function, Body Composition, and Muscle Metabolism in Healthy, Independent Older Adults: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1598-1604. doi: 10.1093/gerona/gly109.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-085
Identifier Type: -
Identifier Source: org_study_id