Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training (PSSMAR)

Parc de Salut Mar

Status

Completed

Conditions

Sarcopenia

Treatments

Dietary Supplement: β-hydroxymethylbutyrate

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02679742

PSSMAR 2015/6288/I

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a resistance training program or placebo with a resistance training program.

Full description

Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function.

The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance.

Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.

Enrollment

32 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female ≥60 years old
sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
being discharged from post-acute care geriatric unit for rehabilitation treatment
ambulatory prior to the recent acute process
cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)
voluntary participation and being able and willing to provide an informed consent

Exclusion criteria

potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
major lower limb surgery over the past 6 months (knee or hip arthroplasty)
contraindication for resistance training
performed regular exercise in the last 6 months
use of any medications interfering with the nutritional intervention
serious clinical conditions that compromises and endanger the patient's life
contraindication, intolerance or allergy to β-hydroxymethylbutyrate