HMB for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a supplement called β-hydroxy-β-methylbutyrate (HMB) can assist people with ALS by assessing its safety and effects on specific blood markers and disease progression. HMB may reduce levels of certain proteins associated with ALS and slow symptom progression. Individuals diagnosed with ALS who can read and understand English may qualify for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that HMB, a compound often used by athletes, is generally safe for humans. People have taken daily doses of about 3 to 4.5 grams without major issues. Studies suggest that using HMB for up to a year does not cause serious side effects. Although detailed safety data for humans remains limited, animal studies have not shown significant problems. Overall, these findings suggest that HMB is well-tolerated, though more detailed human safety data would be helpful.12345
Why do researchers think this study treatment might be promising for ALS?
Most treatments for ALS, like riluzole and edaravone, aim to slow disease progression but don't significantly alter muscle health. Unlike these standard options, β-hydroxy-β-methylbutyrate (HMB) is a compound that may help preserve muscle mass and function. HMB is unique because it is derived from the amino acid leucine and is thought to enhance muscle growth and reduce muscle breakdown. Researchers are excited about HMB because it could offer a new way to support muscle health in ALS patients, potentially improving their quality of life.
What evidence suggests that HMB might be an effective treatment for ALS?
Research has shown that a substance called HMB can increase muscle mass and strength. Some studies suggest that HMB helps build muscle and prevent muscle breakdown, potentially improving muscle function. Although specific evidence for ALS is limited, HMB might reduce certain blood markers linked to the disease. It has shown promise in maintaining muscle health in other conditions, prompting its study in this trial for ALS. However, more research is needed to confirm its effectiveness for ALS patients.35678
Who Is on the Research Team?
Richard Bedlack, MD, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults (18+) diagnosed with ALS who can read and write English, are able to give informed consent, and are expected to live through the study. Women must not be pregnant or able to become pregnant during the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessments including ALSFRS-R score, LEPM-predicted Listener Effort progression, and Motor Movement Exam score. Blood and CSF samples collected for NfL and IGFBP7 levels.
Treatment
Participants receive HMB at a dose of 3g daily. Monthly follow-ups to review adverse events, co-morbidities, and ALSFRS-R score. Blood draws at months 1, 3, and 6 for NfL and IGFBP7 levels.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including final assessments of ALSFRS-R and Listener Effort.
What Are the Treatments Tested in This Trial?
Interventions
- β-hydroxy-β-methylbutyrate (HMB)
Trial Overview
The study tests a supplement called HMB in people with ALS. It looks at how safe and tolerable HMB is, whether it lowers certain blood markers linked to ALS, and if it slows disease progression. All participants receive HMB.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Temple University
Collaborator
Citations
HMB for ALS · Info for Participants
The study tests a supplement called HMB in people with ALS. It looks at how safe and tolerable HMB is, whether it lowers certain blood markers linked to ALS, ...
Health Benefits of β-Hydroxy-β-Methylbutyrate (HMB ... - PMC
Results showed that HMB supplementation in addition to physical exercise has no or fairly low impact in improving body composition, muscle strength, or physical ...
A Systematic Review and Meta-Analysis on Muscle Quality ...
Conclusions: HMB supplementation combined with RT may yield modest improvements in functional performance, particularly handgrip strength and overall physical ...
Study Details | NCT03628365 | Can Beta-Hydroxy ...
The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least ...
hydroxy-β -methylbutyrate on muscle mass and strength in ...
HMB oral supplementation can improve muscle mass, strength, and physical function. We recommend to implement supplementation at a dosage of 3 g for a duration ...
beta-hydroxy-beta-methylbutyrate (HMB) supplementation ...
Although several reports in animals and humans indicate that HMB is safe, quantitative safety data in humans have not been reported definitively. The objective ...
Study Details | NCT07589764 | A Widely Inclusive, Hybrid- ...
This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, ...
Rebuilding Muscle Mass: Protein and HMB
HMB has been used as a supplement to build muscle in athletes safely for many years. We know that a dose of about 3 to 4.5 g/day will not only maintain muscle ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.