MuscleH2AGENCT07419633
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.
A study testing β-Hydroxy-β-methylbutyrate, 2-hydroxybenzylamine and β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine in people with Muscle and Cognitive Functioning, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle, Cognitive Functioning, Geriatric
- What is being tested?
- β-Hydroxy-β-methylbutyrate, 2-hydroxybenzylamine and β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2026to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- •. 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
RI-MUHC
Montreal, Quebec, H4A 3J1
Sharmila Program Manager, 514-984-9975, reachlab@muhc.mcgill.ca
Guy Hajj Boutros, 514-501-9975, guyelhajj@gmail.com
About this study
Official title: The Effects of Beta-Hydroxy-Beta-methylbutyrate (HMB) and/or 2-hydroxybenzylamine (2-HOBA) on Markers of Health Span in Older Adults. A Randomized Control 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.
Read the detailed description
While the concept of using food or food components for medicinal purposes dates back many years ago, the term "nutraceuticals" is gaining respect in present day. Nutraceuticals are described as products that are derived from food sources which provide additional health benefits, include HMB, 2-HOBA, omega-3 fatty acids, probiotics, and antioxidants. These substances show considerable promise in extending health span (period of life spent in good health)through their ability to target aging hallmarks, protect against chronic diseases and enhance cellular resilience.
HMB is a naturally produced substance that is made when the body breaks down an amino acid called leucine, one of the building blocks of protein, which may promote muscle growth. Muscles are made of proteins that are continuously built up and broken down as they are used. When we exercise, we build more muscle proteins than we breakdown, and over time our muscles grow bigger and stronger. When we do not use our muscles (e.g., sedentary behavior), our muscles get smaller and weaker.
This fatty acid occurs in limited quantities within the human body, as only ~5% of dietary leucine converts to HMB. Healthy individuals typically produce 0.2- 0.4 g of HMB per day through normal metabolism.
2-HOBA also known as salicylamine, is a natural substance found in plants such as Himalayan buckwheat. It has demonstrated a reputation that helps protect your cells from damage caused by stress and aging. It may help protect your brain, keep your heart healthy and slow down aging-related damage.
The use of this product is considered experimental, and we may not know all the risks associated with it as yet, but that Health Canada has not objected to its use in this study. Both products are approved by Health Canada separately but no study has been examined the combination of both.
- Conditions
- Muscle, Cognitive Functioning, Geriatric, Ageing and Geriatric Health, Ageing
- Being tested
- β-Hydroxy-β-methylbutyrate, 2-hydroxybenzylamine, β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine, Placebo
- Keywords
- Health, Muscle, Cognitive, Memory, natural product, ageing, natural, supplement, preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-Hydroxy-β-methylbutyrateDietary supplement
Also called HMB (H)
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-hydroxybenzylamineDietary supplement
Also called 2-HOBA (2-H)
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-hydroxybenzylamineDietary supplement
Also called HMB (H) and 2-HOBA (2-H)
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.
PlaceboDietary supplement
Also called Control
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 group | Role | What they receive |
|---|---|---|
| Group 1: HMB group | Experimental | 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. Receives: Dietary Supplement: β-Hydroxy-β-methylbutyrate |
| Group 2: HOBA group | Experimental | 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. Receives: Dietary Supplement: 2-hydroxybenzylamine |
| Group 3: HMB + HOBA group | Experimental | 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. Receives: Dietary Supplement: β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine |
| Group 4: Placebo group (control) | Placebo comparator | 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
Effect of 90 days of HMB and/or 2-HOBA supplements, when administered either individually or in combination, on inflammatory markers.
Characterize changes on inflammatory markers including IL-6, TNF-alpha, CRP before and after 90 days of supplementation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start6 Mar 2026
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MuscleStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a double-blind, placebo-controlled, randomized, parallel-group, multi-arm interventional trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Duque, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Gustavo Duque, Medical Doctor, Principal investigator, McGilll University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419633
- Sponsor's protocol ID
- 2026-11610
- Acronym
- H2AGE
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Beta-Hydroxy-Beta-methylbutyrate (HMB) and/or 2-hydroxybenzylamine (2-HOBA) on Markers of Health Span in Older Adults. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07419633
- Acronym / sponsor ID
- H2AGE / 2026-11610
- Conditions
- Muscle, Cognitive Functioning, Geriatric, Ageing and Geriatric Health, Ageing
- Keywords
- Health, Muscle, Cognitive, Memory, natural product, ageing, natural, supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While the concept of using food or food components for medicinal purposes dates back many years ago, the term "nutraceuticals" is gaining respect in present day. Nutraceuticals are described as products that are derived from food sources which provide additional health benefits, include HMB, 2-HOBA, omega-3 fatty acids, probiotics, and antioxidants. These substances show considerable promise in extending health span (period of life spent in good health)through their ability to target aging hallmarks, protect against chronic diseases and enhance cellular resilience.
HMB is a naturally produced substance that is made when the body breaks down an amino acid called leucine, one of the building blocks of protein, which may promote muscle growth. Muscles are made of proteins that are continuously built up and broken down as they are used. When we exercise, we build more muscle proteins than we breakdown, and over time our muscles grow bigger and stronger. When we do not use our muscles (e.g., sedentary behavior), our muscles get smaller and weaker.
This fatty acid occurs in limited quantities within the human body, as only ~5% of dietary leucine converts to HMB. Healthy individuals typically produce 0.2- 0.4 g of HMB per day through normal metabolism.
2-HOBA also known as salicylamine, is a natural substance found in plants such as Himalayan buckwheat. It has demonstrated a reputation that helps protect your cells from damage caused by stress and aging. It may help protect your brain, keep your heart healthy and slow down aging-related damage.
The use of this product is considered experimental, and we may not know all the risks associated with it as yet, but that Health Canada has not objected to its use in this study. Both products are approved by Health Canada separately but no study has been examined the combination of both.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study is a double-blind, placebo-controlled, randomized, parallel-group, multi-arm interventional trial.
| Arm | Type | Receives |
|---|---|---|
| Group 1: HMB group | Experimental | Dietary Supplement: β-Hydroxy-β-methylbutyrateParticipants 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. |
| Group 2: HOBA group | Experimental | Dietary Supplement: 2-hydroxybenzylamineParticipants 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. |
| Group 3: HMB + HOBA group | Experimental | Dietary Supplement: β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamineParticipants 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. |
| Group 4: Placebo group (control) | Placebo comparator | Dietary Supplement: PlaceboParticipants 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- •. 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
Key exclusion criteria (20 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β-Hydroxy-β-methylbutyrateAlso: HMB (H)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. | Dietary supplement | Group 1: HMB group |
| 2-hydroxybenzylamineAlso: 2-HOBA (2-H)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. | Dietary supplement | Group 2: HOBA group |
| β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamineAlso: HMB (H) and 2-HOBA (2-H)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. | Dietary supplement | Group 3: HMB + HOBA group |
| PlaceboAlso: ControlParticipants 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. | Dietary supplement | Group 4: Placebo group (control) |
Primary outcome
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
Characterize changes in total muscle mass using D3 creatine stable isotope technique before and after 90 days of supplements.
5 secondary outcomes
Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on cardiorespiratory fitness levels (Vo2peak).
Time frame: 12 weeks
Effect of 90 days of HMB and/or 2-HOBA supplements, when administered either individually or in combination, on immune function.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Effect of 90 days of HMB and/or 2-HOBA supplements when administered either individually or in combination on muscle strength.
Time frame: 12 weeks
Effect of 90 days of HMB and/or 2-HOBA supplements, when administered either individually or in combination, on inflammatory markers.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustavo Duque, Medical Doctor principal investigator
McGilll University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-Hydroxy-β-methylbutyrate, 2-hydroxybenzylamine and β-Hydroxy-β-methylbutyrate and 2-hydroxybenzylamine in people with Muscle and Cognitive Functioning, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharmila Program manager (514-984-9975, reachlab@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.