Efficacy of Dietary Supplementation and Physical Activity in Sarcopenic Elderly

Not Applicable

Completed

• Conditions: Sarcopenia

• 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

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
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)
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

Trial Locations

Locations (1)

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