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| Name | Class |
|---|---|
| Goethe University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Urolithin A (Mitopure) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Softgel containing placebo | Dietary Supplement | Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentages of CD3+ T-cell immune cell population | In particular, number of CD8+ T memory stem cells (identified by expression of CD8+CD45RA+CCR7+CD95+) and naïve-like T cells (CD8+CD45RA+CCR7+CD95-) | 28 days |
| Change in Mitochondrial activity in CD3+ T-cells | Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation | 28 days | |
| Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry |
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Inclusion Criteria:
Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)
Exclusion Criteria:
Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Dominic Denk, MD | Universitätsklinikum Frankfurt Medizinische Klinik I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany | Frankfurt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41174221 | Derived | Denk D, Singh A, Kasler HG, D'Amico D, Rey J, Alcober-Boquet L, Gorol JM, Steup C, Tiwari R, Kwok R, Arguello RJ, Faitg J, Sprinzl K, Zeuzem S, Nekljudova V, Loibl S, Verdin E, Rinsch C, Greten FR. Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial. Nat Aging. 2025 Nov;5(11):2309-2322. doi: 10.1038/s43587-025-00996-x. Epub 2025 Oct 31. |
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| ID | Term |
|---|---|
| C026423 | 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one |
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| Softgel containing 250mg of Urolithin A (Mitopure) | Dietary Supplement | Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days |
|
| 28 days |
| Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry | 28 days |
| Change in gene-expression: single cell analysis of CD3+ T-cells | 28 days |
| Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation | 28 days |
| Change in Lipid profile | 28 days |
| Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age) | 28 days |
| Number of adverse events | 28 days |