Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07202403

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Aging Longevity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atria Research and Global Health Institute

New York, 10022, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spermidine

Dietary Supplement

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.

Primary outcomes

  1. Safety and tolerability

    Time frame: 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 outcomes

  1. Change in systemic immune milieu

    Time frame: 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.

  2. Change in systemic metabolic milieu

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Atria Research and Global Health Institute (ARGHI)

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.