This Study Investigates β-hydroxy-β-methylbutyrate (HMB) and 2-hydroxybenzylamine (2-HOBA), When Administered Either Individually or in Combination Contributes to an Increased Quality of Health, Specifically Improving Muscular Strength and Cognitive Functioning in Adults Over the Age of 65.

NCT07419633 | Recruiting DMC

• 1 other identifier: 2026-11610
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, participants will be assigned to receive HMB, 2-HOBA, a combination of both, or a comparison supplement for a set period of time. During the study, participants will attend scheduled visits where researchers will assess muscle strength, physical function, and overall health. Blood samples may be collected to measure markers related to metabolism, inflammation, and oxidative stress. Study staff will also monitor safety and any side effects throughout the study.

Conditions

Muscle; Cognitive Functioning; Geriatric; Ageing and Geriatric Health; Ageing

Keywords

Health; Muscle; Cognitive; Memory; natural product; ageing; natural; supplement; preservation

Outcome Measures

Primary Outcomes (1)

• Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on muscle mass.

  Characterize changes in total muscle mass using D3 creatine stable isotope technique before and after 90 days of supplements.

  12 weeks

Secondary Outcomes (5)

• Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on cardiorespiratory fitness levels (Vo2peak).

  12 weeks

• Effect of 90 days of HMB and/or 2-HOBA supplements, when administered either individually or in combination, on immune function.

  12 weeks

• Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on cognitive function using the CANTAB cognitive tools.

  12 weeks

• Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on muscle strength.

  12 weeks

• Effect of 90 days of HMB and/or 2-HOBA supplements, when administered either individually or in combination, on inflammatory markers.

  12 weeks

Study Arms (4)

Group 1: HMB group

EXPERIMENTAL

Participants in intervention group HMB (H) will receive HMB supplementation (β-hydroxy-β-methylbutyrate and Cholecalciferol) at a dose of 3g/day, consisting of 2 tablets of 750mg each, twice daily.

Dietary Supplement: β-Hydroxy-β-methylbutyrate

Group 2: HOBA group

EXPERIMENTAL

Participants in the intervention group (2-H) will receive 2-HOBA (2-hydroxybenzylamine and Cholecalciferol) at a dose of 650mg/day, respectively consisting of 2 tablets of 162.5mg each, twice daily.

Dietary Supplement: 2-hydroxybenzylamine

Group 3: HMB + HOBA group

EXPERIMENTAL

Participants in the intervention group (H-2-H) will receive HMB + 2-HOBA (β-hydroxy-β-methylbutyrate and 2-hydroxybenzylamine and Cholecalciferol) at a dose of 3g and 650 mg/day, respectively, consisting of 2 tablets of 750mg and 325mg each, twice daily.

Dietary Supplement: β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine

Group 4: Placebo group (control)

PLACEBO COMPARATOR

Participants in control group (c) will receive 2 tablets- twice daily (Calcium Lactate and Cholecalciferol), each containing the same ingredients, placebo will be identical color and weight matched tablets with excipients (no HMB and no 2-HOBA).

Dietary Supplement: Placebo

Interventions

β-Hydroxy-β-methylbutyrate DIETARY_SUPPLEMENT

Participants in intervention group HMB (H) will receive HMB supplementation at a dose of 3g/day, consisting of 2 tablets of 750mg each, twice daily for a period of 90 days.

Also known as: HMB (H)

Group 1: HMB group

2-hydroxybenzylamine DIETARY_SUPPLEMENT

Participants in the intervention group (2-H) will receive 2-HOBA at a dose of 650mg/day, respectively consisting of 2 tablets of 162.5mg each, twice daily for a period of 90 days.

Also known as: 2-HOBA (2-H)

Group 2: HOBA group

β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine DIETARY_SUPPLEMENT

Participants in the intervention group (H-2-H) will receive HMB + 2-HOBA at a dose of 3g and 650 mg/day, respectively, consisting of 2 tablets of 750mg and 325mg each, twice daily for a period of 90 days.

Also known as: HMB (H) and 2-HOBA (2-H)

Group 3: HMB + HOBA group

Placebo DIETARY_SUPPLEMENT

Participants in control group (c) will receive 2 tablets- twice daily, each containing the same ingredients, placebo will be identical color and weight matched tablets with excipients (no HMB and no 2-HOBA) for a period of 90 days.

Also known as: Control

Group 4: Placebo group (control)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• . 65 years of age
• English or French speaking
• Females not of childbearing potential
• Willing to maintain current lifestyle and dietary habits, including level of physical activity, allowed medication/supplements habits for the duration of the study

You may not qualify if:

• Known cardiac diseases, known arterial fibrillation, hepatic diseases, immune diseases (e.g. Individuals with an acute infectious disease, autoimmune disease or are immune compromised), ulcers, asthma, gout, severe anemia, hay fever, nasal polyps.
• Chronic kidney disease \[estimated glomerular filtration rate (GFR) \< 35 mL/min\].
• Neurological injury/disorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, myopathy, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy).
• Neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
• History of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the Medical Research Council Dyspnea Scale.
• Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks before screening are not eligible.
• Underlying muscle diseases, including a history of or currently active myopathy (e.g., dermatomyositis, polymyositis, etc.) or muscular dystrophies.
• Confirmed rheumatoid arthritis, acquired immunodeficiency syndrome (AIDS), type 1 or type 2 diabetes mellitus.
• History of cancer in the last 6 months.
• Not on any medications including NHPs/living with medical conditions that would compromise the study outcome or the safety of the research participant.
• Known allergy to study medication or its components (non-medicinal ingredients).
• Allergy to aspirin/salicylate or if using other drugs containing acetylsalicylic acid or other salicylates and a history of ASA-sensitive asthma/bronchospasm
• The following list of medications/NHPs will be excluded (and weaned as seen necessary by the study physician) prior to and during the study:
• Participants on newly initiated cholesterol-lowering medication will be excluded. Those on stable regimens for ≥3 months will be included and will be monitored for potential interactions as per the HMB monograph.
• Medications associated with muscle weakness or immune effects (i.e., oral glucocorticoids).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

RI-MUHC

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Interventions

Protons; 2-(aminomethyl)phenol

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Gustavo Duque, Medical Doctor

  McGilll University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmila Program manager

CONTACT

514-984-9975; reachlab@muhc.mcgill.ca

Guy Hajj Boutros, PhD

CONTACT

514-501-9975; guyelhajj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Director of the Division of Geriatric Medicine - McGill University

Model Details: This study is a double-blind, placebo-controlled, randomized, parallel-group, multi-arm interventional trial.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 19, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-03

Locations

CA (1)