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

NCT07202403 | Enrolling By Invitation

• 1 other identifier: #25-02-400-2231
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Longevity

Keywords

spermidine; aging; longevity; healthspan

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  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 Outcomes (2)

• Change in systemic immune milieu

  Baseline and approximately every 28 days through Day 112 (final study visit).

• Change in systemic metabolic milieu

  Baseline and approximately every 28 days through Day 112 (final study visit).

Study Arms (1)

Spermidine

EXPERIMENTAL

Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.

Dietary Supplement: Spermidine

Interventions

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.

Spermidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atria Research and Global Health Institute (ARGHI): lead

Study Sites (1)

Atria Research and Global Health Institute

New York, New York, 10022, United States

Location

MeSH Terms

Interventions

Spermidine

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)