Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS

Prior treatment

• Prior side effects from HMB deemed to be significant by the investigator

Other illness

• Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study.

Lab values

• Elevated serum calcium or vitamin D levels.

Other

• Actively or recently (within past 30 days) participating in another intervention trial.
• Currently or recently (within 30 days) taking HMB
• Pregnant women or women currently breastfeeding.
• Life expectancy shorter than the duration of the trial.

• Male or female aged at least 18 years.
• Sporadic or familial ALS diagnosed as per Gold Coast Criteria (37).
• Patient is able to understand and express informed consent (in the opinion of the site investigator).
• Patient is able to read and write English.
• Patient is expected to survive for the duration of the trial.
• Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal)
• Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.