HMB + 2-HOBA for Aging
(H2AGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how different supplements might address aging-related issues, such as muscle strength and overall health. Participants will receive either β-hydroxy-β-methylbutyrate (HMB), 2-hydroxybenzylamine (2-HOBA), both, or a placebo, while researchers monitor their health and any side effects. Ideal candidates for this trial are individuals aged 65 or older who speak English or French and are willing to maintain their current lifestyle and diet throughout the study. As an unphased trial, this study allows participants to contribute to valuable research on aging and potentially enhance their own health.
Do I need to stop taking my current medications for the trial?
You may need to stop certain medications or supplements that affect muscle metabolism or immune function, like glucocorticoids or excessive protein supplements. If you're on a stable dose of allowed medications for at least 3 months, you can continue them, but any changes must be reported.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that both HMB and 2-HOBA are safe and well-tolerated in humans. HMB, a nutritional supplement, has been used safely in studies with individuals over 50, showing no significant side effects, including no changes in liver or kidney function, which are important safety measures. Long-term use of HMB, even for up to a year, has been considered safe.
2-HOBA has also undergone safety testing in humans. It was safe and well-tolerated at doses up to 825 mg, with no major side effects reported, even with repeated use. Research has shown that it does not cause cell damage or mutations.
When used together, no negative effects have been noted during treatment periods. This suggests that both HMB and 2-HOBA are generally safe when taken as directed in studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for aging because they introduce unique combinations of ingredients that aren't typically used together in this context. HMB (β-hydroxy-β-methylbutyrate) is known for supporting muscle health, while 2-HOBA (2-hydroxybenzylamine) is being explored for its antioxidant properties. When combined, these compounds may offer a dual approach by supporting muscle maintenance and reducing oxidative stress, which is different from standard aging treatments like lifestyle changes or nutritional supplements. Additionally, the inclusion of cholecalciferol (Vitamin D3) could enhance the benefits by supporting bone health. This combination approach has the potential to offer more comprehensive benefits than traditional methods.
What evidence suggests that this trial's treatments could be effective for aging?
Research has shown that HMB, which participants in this trial may receive, can help older adults increase muscle mass, strength, and physical function. Studies indicate that HMB reduces muscle loss and improves muscle health, which is particularly beneficial as people age. Meanwhile, 2-HOBA, another treatment option in this trial, has demonstrated potential in lowering inflammation and supporting the immune system. It protects the body from harmful molecules that can damage cells. While results can vary among individuals, evidence suggests that both supplements, tested in separate arms of this trial, may improve health outcomes related to aging.13678
Who Is on the Research Team?
Gustavo Duque, Medical Doctor
Principal Investigator
McGilll University Health Centre
Are You a Good Fit for This Trial?
This trial is for adults aged 65 or older who speak English or French, are women past childbearing age, and can keep their usual diet, exercise, and supplement routines during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HMB, 2-HOBA, a combination of both, or a placebo for 12 weeks. Muscle strength, physical function, and overall health are assessed. Blood samples may be collected to measure markers related to metabolism, inflammation, and oxidative stress.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 2-hydroxybenzylamine (2-HOBA)
- β-hydroxy-β-methylbutyrate and 2-hydroxybenzylamine
- β-hydroxy-β-methylbutyrate (HMB)
Trial Overview
Researchers are testing if HMB, 2-HOBA, or both together (compared to a placebo) can improve muscle strength and thinking skills in older adults. Participants will be randomly assigned to one of these groups.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Citations
Inflammation Biomarker Response to Oral 2 ... - PMC
2-HOBA significantly altered the protein biomarkers CCL19, IL-12β, IL-20Rα, TNFβ, and TWEAK, and these may be responsible for the protective effects of 2-HOBA ...
2.
alzdiscovery.org
alzdiscovery.org/uploads/cognitive_vitality_media/2-Hydroxybenzylamine-Cognitive-Vitality-For-Researchers.pdf2-Hydroxybenzylamine
Immune function: 2-HOBA HAS IMMUNOMODULATORY EFFECTS. Aging is associated with increased chronic inflammation and decreased productive immune responses. The ...
2-Hydroxybenzylamine for Treatment of Atrial Fibrillation
2-HOBA was associated with a higher risk of AF recurrence when tested early after AF ablation. This result was unexpected based on preclinical ...
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL ...
The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH.
First-in-human study assessing safety, tolerability, and ... - PMC
The results of this first-in-human study demonstrate that single doses of 2-HOBA acetate up to 825 mg were well tolerated by healthy individuals ...
Safety, tolerability, and pharmacokinetics of repeated oral ...
Repeated oral administration of 2-HOBA was found to be safe and well-tolerated up to 750 mg TID for 15 days.
In vitro safety pharmacology evaluation of 2 ...
Highlights · There is no evidence to suggest 2-hydroxybenzylamine is cytotoxic or mutagenic. · 2-Hydroxybenzylamine does not induce CYP enzyme mRNA expression.
2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's ...
2) Evaluate whether 2-HOBA is safe for extended use in patients with early AD. Investigators hypothesize that 2-HOBA will be safe and well ...
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