Aging, Longevity
Conditions
Keywords
spermidine, aging, longevity, healthspan
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSpermidine
Spermidine is a polyamine that forms naturally in plants, animals, and microorganisms as a byproduct of protein breakdown. While it's found in various foods, the highest concentrations are in wheat germ, soy, and fermented foods like cheese and miso (Madeo et al. 2018). Spermidine is known for its role in promoting autophagy, a cellular process that helps to clear damaged cells and improve overall cellular function (Eisenberg et al. 2009; Gabandé-Rodríguez, Gómez de Las Heras, and Mittelbrunn 2019). As a result, spermidine has recently attracted significant scientific interest for its potential to enhance lifespan and overall health in laboratory studies.
Sponsors
Atria Research and Global Health Institute (ARGHI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Baseline to Day 112 | Assessment of toxicity of therapeutic intervention. Toxicity will be assessed through adverse event monitoring conducted at clinic visits or by phone, with adverse events evaluated and graded using CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in systemic immune milieu | Baseline and approximately every 28 days through Day 112 (final study visit). | Change in circulating immune biomarkers from baseline and across dose levels, including cytokines and chemokines and immune cell subsets. |
| Change in systemic metabolic milieu | Baseline and approximately every 28 days through Day 112 (final study visit). | Metabolomics profiling to quantify circulating plasma metabolites and assess dynamic changes at each dose level. |
Countries
United States
Outcome results
None listed