HMB Supplementation in Addition to Multicomponent Exercise in Old Adults (HEAL)

May 9, 2023 updated by: Javier Courel Ibáñez, Universidad de Murcia

Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes

Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. However, the true effect of HMB supplementation combined with a tailored exercise program in frail old adults is still unknown.

Thus, the aim of the HEAL study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to HMB supplementation on old adults' health.

The findings of the HEAL study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • San Javier
      • Murcia, San Javier, Spain, 30720
        • Faculty of Sport Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women aged ≥70 years living in a nursing home
  • Be able to follow an active physical rehabilitation program
  • Be able to read and wright
  • Voluntary participation
  • Capable and willing to provide an informed consent

Exclusion Criteria:

  • Acute heart attack (recent 3-6 months) or unstable angina
  • Uncontrolled atrial or ventricular arrhythmias
  • Aortic dissecting aneurysm
  • Severe aortic stenosis
  • Acute endocarditis / pericarditis
  • Uncontrolled high blood pressure (>180/100 mmHg)
  • Acute thromboembolism
  • Acute or severe heart failure
  • Acute or severe respiratory failure
  • Uncontrolled postural hypotension
  • Uncontrolled acute decompensated diabetes mellitus or low blood sugar
  • A recent fracture in the last month.
  • Coincident participation in any intervention trial
  • HMB contraindication, intolerance, or allergy
  • Community-dwelling people
  • Have regularly performed exercise (>20 minutes >3 days/week) in the last 3 months
  • Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix)
  • Revascularization within 1 year
  • Severe loss of vision, hearing, or communicative ability
  • Conditions preventing cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controls
No intervention
Experimental: Ex-HMB
HMB dietary supplementation and Multicomponent physical exercise program
Dietary supplement: HMB dietary supplementation
Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
Other: Multicomponent physical exercise program
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
Experimental: NoEx-HMB
HMB Dietary supplementation
Dietary supplement: HMB dietary supplementation
Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
Placebo Comparator: Ex-Plac
Multicomponent physical exercise program
Other: Multicomponent physical exercise program
Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
Time Frame: Baseline to 25 Weeks
Summary scores range from 0-12 and higher scores denote higher physical performance.
Baseline to 25 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Handgrip strength (kg)
Time Frame: Baseline to 25 Weeks
Using a dynamometer
Baseline to 25 Weeks
Change in lower-body strength (kg)
Time Frame: Baseline to 25 Weeks
Seated leg press one-repetition maximun test
Baseline to 25 Weeks
Change in upper-body strength (kg)
Time Frame: Baseline to 25 Weeks
Vertical bench press one-repetition maximun test
Baseline to 25 Weeks
Change in lower-body strength power output (m/s)
Time Frame: Baseline to 25 Weeks
Seated leg press load-velocity profile
Baseline to 25 Weeks
Change in upper-body strength power output (m/s)
Time Frame: Baseline to 25 Weeks
Vertical bench press load-velocity profile
Baseline to 25 Weeks
Change in frailty (score)
Time Frame: Baseline to 25 Weeks
Frailty phenotype determination using Fried's criteria
Baseline to 25 Weeks
Change in lean body mass (kg)
Time Frame: Baseline to Week 25
Change in lean body mass using dual energy x-ray absorptiometry
Baseline to Week 25
Change in lipid profile
Time Frame: Baseline to Week 25
Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)
Baseline to Week 25
Change in glycaemic profile
Time Frame: Baseline to Week 25
Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)
Baseline to Week 25
Change in Thyroid-Stimulating Hormone (mIU/L)
Time Frame: Baseline to Week 25
Baseline to Week 25
Change in Disability (Lawton index scores)
Time Frame: Baseline to 25 Weeks
Disability in instrumental activities of daily living.
Baseline to 25 Weeks
Change in Disability (Barthel index scores)
Time Frame: Baseline to 25 Weeks
Disability in basic activities of daily living
Baseline to 25 Weeks
Change in Comorbidity (score)
Time Frame: Baseline to 25 Weeks
When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes
Baseline to 25 Weeks
Change in cognitive function (score)
Time Frame: Baseline to 25 Weeks
Using the Mini-Mental State Examination
Baseline to 25 Weeks
Change in depression (score)
Time Frame: Baseline to 25 Weeks
Using the 15-item Yesavage geriatric depression
Baseline to 25 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2019

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2131/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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