Nutrition and Exercise for Sarcopenia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00872911 |
Recruitment Status :
Completed
First Posted : March 31, 2009
Last Update Posted : December 12, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcopenia | Dietary Supplement: Amino acids Drug: Exercise | Phase 1 |
Our preliminary studies indicate that, in older adults, muscle protein anabolism is normally stimulated by amino acids alone, but impaired when nutritional stimuli contain carbohydrate due to a relative insulin resistance of muscle protein synthesis. We have also found that amino acids are the most efficient nutrients for the acute stimulation of muscle protein anabolism and our pilot data suggest that they can also increase muscle mass in healthy older adults.
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:
- Nutritional supplementation with amino acids will improve muscle mass, strength, function, quality, and protein synthesis.
- Progressive exercise training for 24 weeks will improve muscle mass strength,function, quality, perfusion, and protein metabolism.
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Nutrition and Exercise to Improve Protein Metabolism and Prevent Sarcopenia in Aging |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Nutritional supplement |
Dietary Supplement: Amino acids
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d |
Experimental: Placebo + Exercise |
Drug: Exercise
progressive exercise training |
Experimental: Nutritional Supplement + Exercise |
Dietary Supplement: Amino acids
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d Drug: Exercise progressive exercise training |
No Intervention: Placebo |
- Muscle mass [ Time Frame: 6 months ]
- Muscle function [ Time Frame: 6 months ]
- muscle protein turnover [ Time Frame: 6 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years to 85 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age 65-85 yrs
- ability to sign consent form (score >25 on the 30 item Mini Mental State Examination, MMSE)
- stable body weight for at least 1 year (verified via medical records).
Exclusion Criteria:
- physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (≥2/year) or significant weight loss in the past year)
- exercise training (≥2 weekly sessions of moderate-to-high intensity aerobic or resistance exercise)
- significant heart, liver, kidney, blood or respiratory disease
- peripheral vascular disease
- diabetes or other untreated endocrine disease
- active cancer
- recent (within 6 months) treatment with anabolic steroids, or corticosteroids
- alcohol or drug abuse
- tobacco use (smoking or chewing, verified via medical records)
- depression (>5 on the 15-item Geriatric Depression Scale (GDS))
- malnutrition (BMI <20 kg/m2; hypoalbuminemia or hypotransferrenemia; protein intake<0.66 g/kg/day at run-in)
- obesity (BMI>30 kg/m2).

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): NCT00872911
United States, Texas | |
Sealy Center on Aging, University of Texas Medical Branch | |
Galveston, Texas, United States, 77550 |
Principal Investigator: | Elena Volpi, MD,PhD | The University of Texas Medical Branch, Galveston |
Responsible Party: | The University of Texas Medical Branch, Galveston |
ClinicalTrials.gov Identifier: | NCT00872911 |
Other Study ID Numbers: |
08-085 5R01AG030070 ( U.S. NIH Grant/Contract ) |
First Posted: | March 31, 2009 Key Record Dates |
Last Update Posted: | December 12, 2016 |
Last Verified: | December 2016 |
Sarcopenia nutrition aging metabolism exercise |
Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical |