Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: placebo; Dietary Supplement: dietary supplement

• Registration Number: NCT02402608
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-03
• Study First Submitted: 2015-03-22
• Study First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Study First Posted: 2015-03-30
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product
dietary supplement	dietary supplement	oral essential amino acid (EAA), whey protein and vitamin D mixture (32 g)

Primary Outcome Measures

Name	Time	Method
muscle mass assessed by dual x-ray absorptiometry	3 months	muscle mass assessed by dual x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
muscle strength assessed by handgrip dynamometer	3 months	muscle strength assessed by handgrip dynamometer
quality of life assessed by SF-36	3 months	quality of life assessed by SF-36
inflammation assessed by C-reactive protein	3 months	inflammation assessed by C-reactive protein
malnutrition assessed by Mini Nutritional Assessment	3 months	malnutrition assessed by Mini Nutritional Assessment
functionality assessed by activity daily living	3 months	assessed by activity daily living
fat mass distribution assessed by DXA	3 months	body composition assessed by DXA
GH-IGF-I axsis by Insulin like growth factor -I (IGF-I)	3 months	Insulin like growth factor -I (IGF-I)

Trial Locations

Locations (1)

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