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

September 29, 2025 updated by: Atria Research and Global Health Institute (ARGHI)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10022
        • Atria Research and Global Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spermidine
Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.
Dietary supplement: Spermidine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Day 112

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and approximately every 28 days through Day 112 (final study visit).
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.
Baseline and approximately every 28 days through Day 112 (final study visit).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atria Research and Global Health Institute (ARGHI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

September 29, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #25-02-400-2231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To safeguard participant privacy, only fully de-identified data may be shared with qualified researchers under appropriate data use agreements and in compliance with all applicable privacy regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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