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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Group 1: HMB groupExperimental treatment 1 intervention
Group B: Group 2: HOBA groupExperimental treatment 1 intervention
Group C: Group 3: HMB + HOBA groupExperimental treatment 1 intervention
Group D: Group 4: Placebo group (control)Placebo comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

Characterize changes in cardiorespiratory fitness levels (Vo2peak), using an indirect calorimeter, before and after 90 days of supplements.

Time frame
12 weeks
2

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

Characterize changes in immune function including neutrophil/lymphocyte and response to immune challenge, before and after 90 days of supplements

Time frame
12 weeks
3

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.

Characterize changes in cognitive function including attention using memory, executive function, reaction time and delayed match sample testings, before and after 90 days of supplements.

Time frame
12 weeks
4

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

Lower limb muscle strength will be assessed using a biodex dynamometer in older adults before and after 90 days of supplements

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.