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NCT05735886
Urolithin A Supplementation to Boost Immune Health
Completed
NA
Last updated 26 September 2024
What this trial tests
NA trial testing Softgel containing placebo in Aging in 50 participants. Completed in 31 August 2024.
Timeline
30 January 2023
Primary endpoint
31 March 2024
31 March 2024
31 August 2024
Quick facts
| Lead sponsor | Amazentis SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 50 |
| Start date | 30 January 2023 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 August 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Softgel containing placebo
- Softgel containing 250mg of Urolithin A (Mitopure)
Conditions studied
- Aging — all drugs for Aging →
Sponsor
Amazentis SA — full company profile →
Who can join
Adults 45 to 70, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mitochondrial dysfunction: mechanisms and advances in therapy.
Zong Y, Li H, Liao P, Chen L, et al · · 2024 · cited 614× · PMID 38744846 · DOI 10.1038/s41392-024-01839-8 -
The mitophagy pathway and its implications in human diseases.
Wang S, Long H, Hou L, Feng B, et al · · 2023 · cited 484× · PMID 37582956 · DOI 10.1038/s41392-023-01503-7 -
Mitophagy Activation by Urolithin A to Target Muscle Aging.
Faitg J, D'Amico D, Rinsch C, Singh A. · · 2024 · cited 11× · PMID 37925671 · DOI 10.1007/s00223-023-01145-5 -
Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial.
Denk D, Singh A, Kasler HG, D'Amico D, et al · · 2025 · cited 2× · PMID 41174221 · DOI 10.1038/s43587-025-00996-x -
CDK12 Inactivation Attenuates Prostate Cancer Progression by Inhibiting BNIP3-Mediated Mitophagy.
Huang M, Lei H, Tong T, Zou H, et al · · 2026 · cited 2× · PMID 40605142 · DOI 10.1111/cpr.70091 -
Mitophagy in the pathogenesis and management of disease.
Wang Q, Sun Y, Li TY, Auwerx J. · · 2026 · cited 1× · PMID 41486294 · DOI 10.1038/s41422-025-01203-7 -
Insights into the therapeutic strategies for aging and aging-associated diseases.
Dong R, Wu Q, Kan J, Fu C, et al · · 2026 · PMID 42225652 · DOI 10.1038/s41392-026-02662-z -
UPLC-MS/MS Method for Simultaneous Quantification of Cyclosporine A and Urolithin A in Plasma and Interspecies Analysis Across Mammals Including Humans.
Heyns IM, Ganugula R, Kumar MNVR, Arora M. · · 2025 · PMID 39959077 · DOI 10.1021/acsomega.4c08515
Verify or expand the search:
- PubMed search for NCT05735886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Amazentis SA trials
Trials by the same sponsor.
- NCT07517913 — Cerebrospinal Fluid Kinetics of Urolithin A · NA · not yet recruiting
- NCT07517874 — Human Skin Safety Testing of 1 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volun · NA · not yet recruiting
- NCT07517887 — Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure · NA · not yet recruiting
- NCT07517900 — Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers · NA · not yet recruiting
- NCT07231783 — The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05735886 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amazentis SA
- Last refreshed: 26 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05735886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing