NCT07419633 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.
| NCT ID | NCT07419633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Muscle |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-03-06 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-03-06 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Gustavo Duque, Medical Doctor
PRINCIPAL INVESTIGATOR
McGilll University Health Centre
Frequently Asked Questions
Who can join the NCT07419633 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Muscle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07419633 currently recruiting?
Yes, NCT07419633 is actively recruiting participants. Contact the research team at reachlab@muhc.mcgill.ca for enrollment information.
Where is the NCT07419633 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07419633 clinical trial?
NCT07419633 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Gustavo Duque, Medical Doctor at McGilll University Health Centre. The trial plans to enroll 120 participants.