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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spermidine | Experimental | Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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-RodrÃguez, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systemic immune milieu | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atria Research and Global Health Institute | New York | New York | 10022 | United States |
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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| ID | Term |
|---|---|
| D013095 | Spermidine |
| ID | Term |
|---|---|
| D011700 | Putrescine |
| D015317 | Biogenic Polyamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
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|
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). |
| D009930 |
| Organic Chemicals |
| D011073 | Polyamines |