Nutrition and Exercise for Sarcopenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by The University of Texas, Galveston.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00872911
First received: March 27, 2009
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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
Sarcopenia
Dietary Supplement: Amino acid supplement
Drug: Exercise

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, 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: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional supplement Dietary Supplement: Amino acid supplement
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
Experimental: Placebo + Exercise Drug: Exercise
progressive exercise training, Definity Microbubbles
Experimental: Nutritional Supplement + Exercise Dietary Supplement: Amino acid supplement
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
Drug: Exercise
progressive exercise training, Definity Microbubbles
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00872911

Contacts
Contact: Elena Volpi, MD, PhD 409-772-1977 evolpi@utmb.edu
Contact: Shaheen Dhanani, MS 409-747-3559 shdhanan@utmb.edu

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

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00872911     History of Changes
Other Study ID Numbers: 08-085, R01 AG030070
Study First Received: March 27, 2009
Last Updated: June 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Sarcopenia
nutrition
aging
metabolism
exercise

Additional relevant MeSH terms:
Sarcopenia
Atrophy
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014