Muscle Quality Index Improvement by Exercise and HMB Oral Supplementation in Older Adults

March 16, 2023 updated by: Ariadna del Villar Morales, National Institute of Rehabilitation, Mexico

Effect of a Power/Resistance Exercise Program and Oral Supplementation With Beta-hydroxy-beta-methyl Butyrate (HMB) on the Muscle Quality Index in Older Adults. A Randomized Controlled Trial

The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function, functional limitations and mortality. The muscle quality index (MQI) is considered a key determinant of muscle function in adulthood. The main treatment to preserve muscle mass has been strength exercise and in some cases the use of aids that influence protein metabolism such as beta-hydroxy-beta-methyl butyrate (HMB), but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the combination of a power/resistance exercise program and oral supplementation with HMB can improve the quality mass index in adults aged compared with those received a single exercise program after 14 weeks of intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design: this is a 14-week, randomized controlled trial. 76 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).

Participants: Adults between 65-75 years old, with a body mass index between 25-30 kg/m^2, sedentaries, non-smokers, with compensated comorbidities, and who do not consume nutritional supplements will be recruited. Participants with uncompensated metabolic diseases, with high risk of falls (evaluated with Tinetti scale), frailty syndrome, and b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users will not be recruited.

Intervention: Participants will be randomized to 1) power/resistance exercise program (GEx), 2) power/resistance exercise program + HMB group (GExHMB) with computer-generated random numbers. The exercise program will consist of training to improve muscular strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. Every training session will consist of 15 minutes of warm-up, 40 to 60 minutes of power/resistance training, neuromuscular and aerobic exercises, and 15 minutes of cool-down. The power/resistance and neuromuscular training will be performed 3 days/week, 2-5 sets, 5-15 repetitions for each exercise according to the recommendation of the American College of Sports Medicine training progression models; the aerobic exercise will be performed 2 days/week. All exercises will be performed at moderate intensity and will take place in the NIR Sports Medicine therapeutic gym.

Oral supplementation with HMB will be from a commercial polymeric formula in liquid form (Ensure Advanced®, 230 ml); the supplement intake will be 1 bottle/day. All patients, regardless of the intervention, will be monitored by sports medicine physicians and nutritionists in order to promote adherence to treatment.

The muscle quality index (MQI) will be obtained from the determination of muscular strength by isokinetic dynamometry (at 60°/s) for the lower extremities and by hand dynamometry for the upper extremities; the lean segmental mass in the upper and lower extremities will be determined by 3-frequency electronic bioimpedance analysis. The MQI will be calculated from the muscular strength divided by the muscular mass.

Lower extremities muscular power will be determined by isokinetic dynamometry at 180°/s, physical performance will be assessed by the Short Physical Performance battery (SPPB) and quality of life perception will be evaluated by the EuroQoL-5D questionnaire. As part of the safety measures for the participants, liver function will be monitored by laboratory tests (liver enzyme profile and general urine test) which will be performed at the NIR laboratory.

For each participant the study length will be 14 weeks with 61 exercise sessions for the GEx and GExHMB groups and 98 days of oral supplementation for the GExHMB group. The beginning of the study corresponds to session 1 of exercise and day 1 of supplementation intake. Initial evaluations will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 14 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators blinded to participant assignment.

Comparison: Comparison group will receive the unique intervention of a strength/resistance exercise program.

Outcomes: The primary outcome is the upper and lower extremities MQI mean change. The secondary outcomes are mean changes in muscular power, physical performance, and health related quality of life.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

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

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index 25-30 km/m^2
  • Appendicular skeletal muscle mass index in women ≥ 5.0 kg/m^2 and men ≥ 6.0 kg/m^2
  • No regular exercise
  • Non-smokers
  • Compensated comorbidities
  • Without consumption of nutritional supplements

Exclusion Criteria:

  • Osteoporosis
  • Cardiovascular diseases (recent heart attack, unstable angina, heart failure, complete atrioventricular block)
  • Musculoskeletal injuries
  • Severe cognitive impairment
  • Major depressive disorder
  • Thyroid diseases
  • Anemia with no response to previous treatment in the last 3 months
  • b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users
  • With amino acid and vitamin D supplementation or suspended with less than 3 months
  • Data of renal insufficiency
  • Chronic obstructive pulmonary disease
  • Malabsorption syndrome associated with malnutrition
  • High risk of falls evaluated with the Tinetti scale (score ≤19)
  • Frailty syndrome

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Power/resistance exercise
Participants on a power/resistance exercise program
Other: Power/resistance exercise program
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
Experimental: Power/resistance exercise + HMB
Participants on combined power/resistance exercise program + HMB oral supplementation
Other: Power/resistance exercise program
participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
Dietary supplement: HMB supplementation
Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline arm Muscle Quality Index (MQIarm)
Time Frame: Baseline and 14 weeks

The muscle quality index from dominant arm will be calculated with data obtained from hand grip strength, and lean mass obtained by bioimpedance analysis according with the formula:

MQIarm = hand grip strength (kg) / arm lean mass (kg)
Baseline and 14 weeks
Mean change from baseline leg Muscle Quality Index (MQIleg)
Time Frame: Baseline and 14 weeks

The muscle quality index from dominant leg will be calculated with data obtained by isokinetic, and lean mass obtained by bioimpedance analysis according with the formula:

MQIleg = peak torque (Nm) / leg lean mass (kg)
Baseline and 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline muscular power
Time Frame: Baseline and 14 weeks
The muscular power will be determined by isokinetic dynamometry at 180°/s
Baseline and 14 weeks
Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 14 weeks
Short Physical Performance Battery scale, range 0-12. The higher the score, the better the physical performance
Baseline and 14 weeks
Health-related quality of life
Time Frame: Baseline and 14 weeks
EuroQol-5D (5 dimension) scale; the lower the level (1-3), the better the health state
Baseline and 14 weeks

Collaborators and Investigators

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

Sponsor

National Institute of Rehabilitation, Mexico

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 (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 34/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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