- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00872911
Nutrition and Exercise for Sarcopenia
Nutrition and Exercise to Improve Protein Metabolism and Prevent Sarcopenia in Aging
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
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Texas
-
Galveston, Texas, Forenede Stater, 77550
- Sealy Center on Aging, University of Texas Medical Branch
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Placebo
|
|
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Eksperimentel: Nutritional supplement
|
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
|
|
Eksperimentel: Placebo + Exercise
|
progressive exercise training
|
|
Eksperimentel: Nutritional Supplement + Exercise
|
mixed pure crystalline amino acids for human use (Ajinomoto), 15 g/d
progressive exercise training
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Muscle mass
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Muscle function
Tidsramme: 6 months
|
6 months
|
|
muscle protein turnover
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elena Volpi, MD,PhD, The University of Texas Medical Branch, Galveston
Publikationer og nyttige links
Generelle 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08-085
- 5R01AG030070 (U.S. NIH-bevilling/kontrakt)
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