Recruiting

HMB & 2-HOBA

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07419633

Conditions

Muscle

Cognitive Functioning

Geriatric

Ageing and Geriatric Health

Ageing

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

β-Hydroxy-β-methylbutyrate

2-hydroxybenzylamine

β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine

Placebo

Study Details

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

Study ID

NCT07419633

Start date

Mar 6, 2026

Status verified date

Mar, 2026

Completion date

Feb 5, 2027

Anticipated

Primary completion date

Feb 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

•. 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

Exclusion Criteria:

  • 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).
  • Medications or supplements affecting skeletal muscle metabolism or weight including: Use of MAO-I's (monoamine oxidase inhibitors), additional consumption of 2-HOBA, Vitamin D or HMB, anabolic steroids, selective androgen receptor modulators (SARMs), corticosteroids, GLP-1s, or other weight loss medications).
  • Excessive protein supplementation (i.e., >2.0 g/kg/day).
  • All participants must be on a stable dose of allowed supplements/medications for at least 3 months prior to enrollment. All concomitant therapies will be documented.

Non-pharmacological interventions that could influence study outcomes (e.g., pulmonary rehabilitation, structured exercise programs) will not be permitted.

Participants undergoing such therapies will be excluded. Any new interventions started during the study must be reported and if judged inappropriate, will result in withdrawal from the trial.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1: HMB group

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.

experimental: Group 2: HOBA group

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.

experimental: Group 3: HMB + HOBA group

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.

placebo comparator: Group 4: Placebo group (control)

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).

Interventions

β-Hydroxy-β-methylbutyrate

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.

2-hydroxybenzylamine

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.

β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine

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.

Placebo

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.

Primary outcome measure

  • Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on muscle mass. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

RI-MUHC

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Principal Investigator:

Gustavo Duque, Medical Doctor

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

May 14, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-05-14.