HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

Aging Clinical Trial

— HEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827499
• Other study ID #: 2131/2018
• Status: Completed
• Phase: N/A
• Start date: March 30, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Frail Elderly Syndrome
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Spain	Faculty of Sport Sciences	Murcia	San Javier

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score	Summary scores range from 0-12 and higher scores denote higher physical performance.	Baseline to 25 Weeks
Secondary	Change in Handgrip strength (kg)	Using a dynamometer	Baseline to 25 Weeks
Secondary	Change in lower-body strength (kg)	Seated leg press one-repetition maximun test	Baseline to 25 Weeks
Secondary	Change in upper-body strength (kg)	Vertical bench press one-repetition maximun test	Baseline to 25 Weeks
Secondary	Change in lower-body strength power output (m/s)	Seated leg press load-velocity profile	Baseline to 25 Weeks
Secondary	Change in upper-body strength power output (m/s)	Vertical bench press load-velocity profile	Baseline to 25 Weeks
Secondary	Change in frailty (score)	Frailty phenotype determination using Fried's criteria	Baseline to 25 Weeks
Secondary	Change in lean body mass (kg)	Change in lean body mass using dual energy x-ray absorptiometry	Baseline to Week 25
Secondary	Change in lipid profile	Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)	Baseline to Week 25
Secondary	Change in glycaemic profile	Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)	Baseline to Week 25
Secondary	Change in Thyroid-Stimulating Hormone (mIU/L)		Baseline to Week 25
Secondary	Change in Disability (Lawton index scores)	Disability in instrumental activities of daily living.	Baseline to 25 Weeks
Secondary	Change in Disability (Barthel index scores)	Disability in basic activities of daily living	Baseline to 25 Weeks
Secondary	Change in Comorbidity (score)	When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes	Baseline to 25 Weeks
Secondary	Change in cognitive function (score)	Using the Mini-Mental State Examination	Baseline to 25 Weeks
Secondary	Change in depression (score)	Using the 15-item Yesavage geriatric depression	Baseline to 25 Weeks