Nutrition and Exercise for Sarcopenia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: March 27, 2009
Last updated: September 8, 2015
Last verified: September 2015
The investigators' general hypothesis is that nutritional factors, including protein/energy malnutrition and/or an impaired response of muscle to nutrition, and inactivity play significant roles in developing sarcopenia, the involuntary loss of muscle mass and function with age. Therefore, age-specific prolonged interventions including nutritional manipulations and/or exercise may help to reduce, stabilize, or even reverse sarcopenia.

Condition Intervention Phase
Dietary Supplement: Amino acids
Drug: Exercise
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutrition and Exercise to Improve Protein Metabolism and Prevent Sarcopenia in Aging

Resource links provided by NLM:

Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Muscle mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • muscle protein turnover [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: March 2009
Estimated Study Completion Date: August 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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:

  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.


Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. age 65-85 yrs
  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:

  1. 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)
  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).
  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 identifier: NCT00872911

United States, Texas
Sealy Center on Aging, University of Texas Medical Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Principal Investigator: Elena Volpi, MD,PhD The University of Texas Medical Branch, Galveston
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00872911     History of Changes
Other Study ID Numbers: 08-085  R01AG030070 
Study First Received: March 27, 2009
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Medical Branch, Galveston:

Additional relevant MeSH terms:
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms processed this record on May 24, 2016