Study record
Urolithin A first-in-human: safety and a mitochondrial gene signature (Andreux et al., 2019)
Human RCT — biomarker endpoint
○ Evidence tier 4 — Human RCT — biomarker endpoint
Record verify: primary source pending
| Design | First-in-human randomized, placebo-controlled safety study (biomarker) |
| DOI | 10.1038/s42255-019-0073-4 |
| Citation status | doi verified via Crossref 2026-07-12 (Nat Metab 2019;1(6):595-603, Andreux et al., 'The mitophagy activator urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans'). PMID + NCT: needs_primary_fulltext. |
Five-qualifier claim
| Species / population | Healthy sedentary older adults, first-in-human randomized placebo-controlled study plus a single-dose/repeated-dose safety design. |
| Exposure, route, schedule | Oral urolithin A (single ascending doses and 28-day repeated dosing, up to ~1000 mg/day). |
| Comparator / duration | Placebo-controlled; short (single-dose and 4-week) exposure. |
| Endpoint / numeric result | Urolithin A was safe and bioavailable and induced a molecular (gene-expression) signature of improved mitochondrial and cellular health in skeletal muscle; no adverse safety signal. |
| What it did NOT establish | A safety/biomarker first-in-human study — no functional or clinical efficacy endpoint met, and no lifespan or healthy-aging outcome. |
Interventions
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; anything marked needs_primary_fulltext is not yet confirmed.