- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00872911
Nutrition and Exercise for Sarcopenia
Nutrition and Exercise to Improve Protein Metabolism and Prevent Sarcopenia in Aging
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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-
Texas
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Galveston, Texas, Förenta staterna, 77550
- Sealy Center on Aging, University of Texas Medical Branch
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Placebo
|
|
Experimentell: Nutritional supplement
|
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
|
Experimentell: Placebo + Exercise
|
progressive exercise training
|
Experimentell: Nutritional Supplement + Exercise
|
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
progressive exercise training
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Muscle mass
Tidsram: 6 months
|
6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Muscle function
Tidsram: 6 months
|
6 months
|
muscle protein turnover
Tidsram: 6 months
|
6 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Elena Volpi, MD,PhD, The University of Texas Medical Branch, Galveston
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 08-085
- 5R01AG030070 (U.S.S. NIH-anslag/kontrakt)
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