Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spermidine.
- Who it may be relevant to
- Registry conditions: Aging, Longevity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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 20
Primary outcome measures
- Safety and tolerability [Time frame: Baseline to Day 112]
Secondary outcome measures (2)
- Change in systemic immune milieu [Time frame: 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Atria Research and Global Health Institute — New York
Identifiers
NCT: NCT07202403 · #25-02-400-2231