Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HMB Supplementation and Motor Performance in Sarcopenic Patiens

NCT06801808

Sarcopenia

NOT_YET_RECRUITING NA

Strategies to Reduce Organic Muscle Atrophy in the Intensive Care Unit

NCT02773771

Muscle Atrophy

WITHDRAWN PHASE2/PHASE3

Resistance Exercise or Vibration With HMB for Sarcopenia

NCT04028206

Sarcopenia

UNKNOWN NA

Short-Term Resistance Training in Older Adults

NCT04266678

Sarcopenia Muscle Quality

COMPLETED NA

Respiratory Muscle Training in Subacute Stroke Patients

NCT02125760

Muscle Weakness

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

β-hydroxymethylbutyrate

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program

Group Type EXPERIMENTAL

β-hydroxymethylbutyrate

Intervention Type DIETARY_SUPPLEMENT

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Placebo

Maltodextrin 3 grams once a day combined with a resistance training program

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

β-hydroxymethylbutyrate

β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No