Clinical trial NCT02402608: Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly
Official title: Whey Protein, Amino Acids and Vitamin D Supplementation With Physical Activity Increases Muscle Mass and Strength, Functionality and Quality of Life and Decreases Inflammation in Sarcopenic Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2015-03-30
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Eligible patients were aged 65 years or older with appendicular skeletal muscle mass/height2 2SD below mean of young adults (Baumgartner R, 1998), so with relative muscle mass \< 7.26 kg/m2 for men and \< 5.5 kg/m2 for women.
* Patients were not affected by acute illness, severe liver, heart or kidney dysfunction, and had a body weight which had been stable for 6 months

Exclusion Criteria:

* Subjects with altered glycometabolic control, disthyroidism and other endocrinopathies and cancers, as well as patients treated with steroids and heparin, or with total walking incapacity were excluded.

Primary outcomes:
measure: muscle mass assessed by dual x-ray absorptiometry
timeFrame: 3 months
Secondary outcomes:
measure: muscle strength assessed by handgrip dynamometer
timeFrame: 3 months
measure: quality of life assessed by SF-36
timeFrame: 3 months
measure: inflammation assessed by C-reactive protein
timeFrame: 3 months
measure: malnutrition assessed by Mini Nutritional Assessment
timeFrame: 3 months
measure: functionality assessed by activity daily living
timeFrame: 3 months
measure: fat mass distribution assessed by DXA
timeFrame: 3 months
measure: GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
Study officials:
affiliation: University of Pavia
name: mariangela rondanelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.