HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

NCT ID: NCT03827499

Last Updated: 2023-05-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-30

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging Frail Elderly Syndrome Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Ex-HMB

HMB dietary supplementation and Multicomponent physical exercise program

Group Type EXPERIMENTAL

HMB dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Multicomponent physical exercise program

Intervention Type OTHER

Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.

NoEx-HMB

HMB Dietary supplementation

Group Type EXPERIMENTAL

HMB dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Ex-Plac

Multicomponent physical exercise program

Group Type PLACEBO_COMPARATOR

Multicomponent physical exercise program

Intervention Type OTHER

Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.

Controls

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Javier Courel Ibáñez

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Sport Sciences

Murcia, San Javier, Spain

Site Status

Countries

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Spain

References

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Courel-Ibanez J, Pallares JG; HEAL study group. Effects of beta-hydroxy-beta-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.

Reference Type DERIVED
PMID: 31277595 (View on PubMed)

Other Identifiers

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2131/2018

Identifier Type: -

Identifier Source: org_study_id

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