Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Azienda di Servizi alla Persona di Pavia130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

130

Conditions

Sarcopenia

Interventions

dietary supplementDIETARY_SUPPLEMENT

oral essential amino acid (EAA), whey protein and vitamin D mixture

placeboDIETARY_SUPPLEMENT

placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia

Pavia, Pavia, Italy

Outcomes

Primary Outcomes

muscle mass assessed by dual x-ray absorptiometry

Time frame: 3 months

Secondary Outcomes

muscle strength assessed by handgrip dynamometer

Time frame: 3 months

quality of life assessed by SF-36

Time frame: 3 months

inflammation assessed by C-reactive protein

Time frame: 3 months

malnutrition assessed by Mini Nutritional Assessment

Time frame: 3 months

functionality assessed by activity daily living

assessed by activity daily living

Time frame: 3 months

fat mass distribution assessed by DXA

body composition assessed by DXA

Time frame: 3 months

GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)

Insulin like growth factor -I (IGF-I)

Time frame: 3 months

Data from ClinicalTrials.gov

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