AgingNCT07202403
Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
A study testing Spermidine in people with Aging and Longevity, run by Atria Research and Global Health Institute (ARGHI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Spermidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75
- Patients without known significant organ dysfunction, based on standard blood tests within the last year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atria Research and Global Health Institute
New York, New York, 10022
About this study
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.
- Being tested
- Spermidine
- Keywords
- spermidine, aging, longevity, healthspan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Spermidine | Experimental | Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg. Receives: Dietary Supplement: Spermidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 112
Secondary outcomes (2)
Change in systemic immune milieu
Change in circulating immune biomarkers from baseline and across dose levels, including cytokines and chemokines and immune cell subsets.
Measured: Baseline and approximately every 28 days through Day 112 (final study visit).
Change in systemic metabolic milieu
Metabolomics profiling to quantify circulating plasma metabolites and assess dynamic changes at each dose level.
Measured: Baseline and approximately every 28 days through Day 112 (final study visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start7 Jan 2025
- Primary completion17 Jun 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atria Research and Global Health Institute (ARGHI)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202403
- Sponsor's protocol ID
- #25-02-400-2231
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
- ClinicalTrials.gov ID
- NCT07202403
- Acronym / sponsor ID
- #25-02-400-2231
- Keywords
- spermidine, aging, longevity, healthspan
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Atria Research and Global Health Institute (ARGHI)University, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spermidine | Experimental | Dietary Supplement: SpermidineParticipants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 75
- Patients without known significant organ dysfunction, based on standard blood tests within the last year
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpermidineSpermidine 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. | Dietary supplement | Spermidine |
Primary outcome
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spermidine in people with Aging and Longevity, run by Atria Research and Global Health Institute (ARGHI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Baseline to Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.