120 Participants NeededMy employer runs this trial

HMB + 2-HOBA for Aging

(H2AGE Trial)

SP
GH
Overseen ByGuy Hajj Boutros, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.12345

Why 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?

GD

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

I can speak English or French.
I am 65 years old.
* Females not of childbearing potential
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks
Scheduled visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Group 3: HMB + HOBA groupExperimental Treatment1 Intervention
Group II: Group 2: HOBA groupExperimental Treatment1 Intervention
Group III: Group 1: HMB groupExperimental Treatment1 Intervention
Group IV: Group 4: Placebo group (control)Placebo Group1 Intervention

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

Trials
476
Recruited
170,000+

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-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 ...