Urolithin A first-in-human: safety and a mitochondrial gene signature (Andreux et al., 2019)
Human RCT — biomarker endpoint
Record verify: source publication identified; see evidence and limitations
| Design | First-in-human randomized, placebo-controlled safety study (biomarker) |
| N | 60 |
| Registry | NCT02655393 |
| DOI | 10.1038/s42255-019-0073-4 |
| Citation status | Original publication identity matched by title, author and DOI; relevant full-text sections, results and limitations examined 2026-10-14. Full original text was accessed through the documented co-author upload; publication identification is separate from interpretation of results. |
Identifiers: DOI verified; PMID not reported; trial registry id reported, not independently verified. Record-level verification and identifier-level status are separate: a record can be verified against its primary publication on one identifier while another is simply not confirmed. No identifier is fabricated, and none is left in a “pending” state.
Five-qualifier claim
| Species / population | 60 healthy, sedentary adults aged61–85 at one French clinical center:24 in single-dose and36 in repeated-dose cohorts. All enrolled participants completed the study. |
| Exposure, route, schedule | Single oral doses of250,500,1000 or2000mg urolithin A, including food-matrix comparisons at500/1000mg; daily250,500 or1000mg for28days in separate cohorts. |
| Comparator / duration | Placebo-controlled; short (single-dose and 4-week) exposure. |
| Endpoint / numeric result | The primary short-term safety/tolerability outcome was met, with no serious or product-related adverse events. Urolithin A was bioavailable;500/1000mg daily changed plasma acylcarnitines and muscle gene-expression markers. Mitochondrial DNA abundance did not significantly increase. |
| What it did NOT establish | Physiological performance endpoints were not evaluated; this was not a failed functional-endpoint trial. The short Phase1 study does not establish clinical efficacy, long-term safety or human lifespan benefit. |
Interventions
Related retailer search
These links open retailer searches for related supplement brands. They do not verify the brand, formulation or dose used in this individual trial, or the contents of any current listing. The study doses and outcomes are reported in the record above. No personal dose is recommended.
- Urolithin A
Find Urolithin A on Amazon →
Links marked with an arrow are affiliate links: MitoiX may earn a commission from qualifying purchases. Retailers determine prices and purchase terms. This never affects what is published — see the affiliate disclosure.
Primary reference
https://doi.org/10.1038/s42255-019-0073-4
Exact identifier confirmed against the primary record via Crossref/ClinicalTrials.gov where stated in the citation status names the source and the date. An identifier that is not confirmed is named as such in the identifier row above, never filled in from a secondary source.