HMB and 2-HOBA to Support Muscle Strength and Thinking in Adults 65+

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will assign participants aged 65 and older to receive beta-hydroxy-beta-methylbutyrate (HMB), 2-hydroxybenzylamine (2-HOBA), a combination of both, or a placebo for a defined period. Researchers will measure muscle strength, physical function, and overall health during scheduled visits, and may collect blood samples to assess metabolism, inflammation, and oxidative stress. The study describes nutraceuticals as potential tools to promote healthy aging by targeting aging-related pathways. Safety monitoring and recording of any adverse effects will occur throughout the trial. The trial is led by McGill University Health Centre with Montreal-site participation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ri-Muhc
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Gustavo Duque, Medical Doctor — McGilll University Health Centre
• Study coordinator: Sharmila Program manager
• Email: reachlab@muhc.mcgill.ca
• Phone: 514-984-9975

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.