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Clinical Trials in Canada / NCT07419633
Recruiting Not applicable

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 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-03-06
Last updated
2026-05-14

Condition(s) studied

MuscleCognitive FunctioningGeriatricAgeing and Geriatric HealthAgeing

Investigational drug(s) / intervention(s)

β-Hydroxy-β-methylbutyrate2-hydroxybenzylamineβ-Hydroxy-β-methylbutyrate and 2-hydroxybenzylaminePlacebo

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.

Study 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

Sex
ALL
Min age
65 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
RI-MUHC Montreal Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07419633 on ClinicalTrials.gov ↗ ← All trials in Canada