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| Name | Class |
|---|---|
| University of Pavia | OTHER |
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This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass, strength, physical functional, quality of life, and decrease the risk of malnutrition and inflammation in sarcopenic elderly.
This 3 months randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation (32 g) with whey protein, essential amino acids and vitamin D concurrent with regular, controlled physical activity would increase muscle mass (assessed by DXA), strength (assessed by handgrip dynamometer), physical functional (assessed by ADL), quality of life (assessed by SF-36), and decrease the risk of malnutrition (assessed by MNA and IGF-I) and inflammation (assessed by C-reactive protein) in sarcopenic elderly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary supplement | Active Comparator | oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g) |
|
| placebo | Placebo Comparator | placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary supplement | Dietary Supplement | oral essential amino acid (EAA), whey protein and vitamin D mixture |
|
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass assessed by dual x-ray absorptiometry | muscle mass assessed by dual x-ray absorptiometry | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| muscle strength assessed by handgrip dynamometer | muscle strength assessed by handgrip dynamometer | 3 months |
| quality of life assessed by SF-36 | quality of life assessed by SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mariangela rondanelli, MD, PhD | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia | Pavia | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25705670 | Background | Rondanelli M, Faliva M, Monteferrario F, Peroni G, Repaci E, Allieri F, Perna S. Novel insights on nutrient management of sarcopenia in elderly. Biomed Res Int. 2015;2015:524948. doi: 10.1155/2015/524948. Epub 2015 Jan 29. | |
| 24225081 | Background | Bjorkman MP, Suominen MH, Pitkala KH, Finne-Soveri HU, Tilvis RS. Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial. Trials. 2013 Nov 14;14:387. doi: 10.1186/1745-6215-14-387. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| placebo | Dietary Supplement | placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product |
|
| 3 months |
| inflammation assessed by C-reactive protein | inflammation assessed by C-reactive protein | 3 months |
| malnutrition assessed by Mini Nutritional Assessment | malnutrition assessed by Mini Nutritional Assessment | 3 months |
| functionality assessed by activity daily living | assessed by activity daily living | 3 months |
| fat mass distribution assessed by DXA | body composition assessed by DXA | 3 months |
| GH-IGF-I axsis by Insulin like growth factor -I (IGF-I) | Insulin like growth factor -I (IGF-I) | 3 months |
| 26864356 | Derived | Rondanelli M, Klersy C, Terracol G, Talluri J, Maugeri R, Guido D, Faliva MA, Solerte BS, Fioravanti M, Lukaski H, Perna S. Whey protein, amino acids, and vitamin D supplementation with physical activity increases fat-free mass and strength, functionality, and quality of life and decreases inflammation in sarcopenic elderly. Am J Clin Nutr. 2016 Mar;103(3):830-40. doi: 10.3945/ajcn.115.113357. Epub 2016 Feb 10. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |