Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies

Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies

This is a multi-cohort, open-label, adaptive trial designed to evaluate the safety, tolerability, and biological effects of dietary supplements and other aging-targeted therapies.

Cohort 1 is a single-arm, open-label, intrapatient dose-escalation study evaluating the effects of escalating doses of spermidine in 10 participants. Patients will have baseline blood drawn and subsequently start daily administration of spermidine. They will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.

Subsequent cohorts will evaluate additional agents.

Inclusion Criteria:

• Adults aged 18 to 75
• Patients without known significant organ dysfunction, based on standard blood tests within the last year

Exclusion Criteria:

• Patients taking any immunomodulatory medications that the investigator or treating physician believe may alter the immune response to the study agent (e.g. biologic antibodies, immunosuppressants)
• Patients actively receiving any therapy that, in the determination of the investigator, may impact the effect of the study agent.
• Patients who, in the opinion of the treating investigator, will not be able to follow treatment and defined follow-up
• Pregnancy