HEAL: HMB Supplementation in Addition to Multicomponent Exercise in Old Adults

• Sponsor: Universidad de Murcia (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03827499
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 34.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Frail Elderly Syndrome; Physical Activity	Dietary Supplement: HMB dietary supplementation; Other: Multicomponent physical exercise program	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes
• Actual Study Start Date: Mar 30, 2019
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Controls No intervention

Outcome Measures

Primary Outcome Measures

1. Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score [Baseline to 25 Weeks]

   Summary scores range from 0-12 and higher scores denote higher physical performance.

Secondary Outcome Measures

1. Change in Handgrip strength (kg) [Baseline to 25 Weeks]

   Using a dynamometer

2. Change in lower-body strength (kg) [Baseline to 25 Weeks]

   Seated leg press one-repetition maximun test

3. Change in upper-body strength (kg) [Baseline to 25 Weeks]

   Vertical bench press one-repetition maximun test

4. Change in lower-body strength power output (m/s) [Baseline to 25 Weeks]

   Seated leg press load-velocity profile

5. Change in upper-body strength power output (m/s) [Baseline to 25 Weeks]

   Vertical bench press load-velocity profile

6. Change in frailty (score) [Baseline to 25 Weeks]

   Frailty phenotype determination using Fried's criteria

7. Change in lean body mass (kg) [Baseline to Week 25]

   Change in lean body mass using dual energy x-ray absorptiometry

8. Change in lipid profile [Baseline to Week 25]

   Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)

9. Change in glycaemic profile [Baseline to Week 25]

   Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)

10. Change in Thyroid-Stimulating Hormone (mIU/L) [Baseline to Week 25]

11. Change in Disability (Lawton index scores) [Baseline to 25 Weeks]

    Disability in instrumental activities of daily living.

12. Change in Disability (Barthel index scores) [Baseline to 25 Weeks]

    Disability in basic activities of daily living

13. Change in Comorbidity (score) [Baseline to 25 Weeks]

    When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes

14. Change in cognitive function (score) [Baseline to 25 Weeks]

    Using the Mini-Mental State Examination

15. Change in depression (score) [Baseline to 25 Weeks]

    Using the 15-item Yesavage geriatric depression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Sport Sciences	Murcia	San Javier	Spain	30720

Sponsors and Collaborators

• Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Javier Courel Ibáñez, Ph.D, Universidad de Murcia
• ClinicalTrials.gov Identifier: NCT03827499
• Other Study ID Numbers: 2131/2018
• First Posted: Feb 1, 2019
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 4, 2020