Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: placebo; Dietary Supplement: dietary supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02402608

ASP-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups, including a placebo group

dietary supplement

Active Comparator group

Description:

oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g)

Treatment:

Dietary Supplement: dietary supplement

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo