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| Name | Class |
|---|---|
| Australian Catholic University | OTHER |
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This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement containing Mitopure | Active Comparator |
| |
| Placebo Supplement | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure | Dietary Supplement | Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma levels over time of creatine kinase (CK) | Muscle damage and recovery biomarker | 4 weeks |
| Change in race performance time during a 3000 m track race in elite runners | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in aerobic capacity (VO2max) | 4-weeks | |
| Change from baseline in running economy via indirect calorimetry | 4-weeks | |
| Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
Trained elite and sub-elite male runners will participate in a sports training camp
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| Name | Affiliation | Role |
|---|---|---|
| Louise Burke, OAM PhD | Australian Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Australian Catholic University/Australian Institute of Sports | Canberra | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40839339 | Derived | Whitfield J, McKay AKA, Tee N, McCormick R, Morabito A, Karagounis LG, Fouassier AM, D'Amico D, Singh A, Burke LM, Hawley JA. Evaluating the Impact of Urolithin A Supplementation on Running Performance, Recovery, and Mitochondrial Biomarkers in Highly Trained Male Distance Runners. Sports Med. 2025 Dec;55(12):3183-3200. doi: 10.1007/s40279-025-02292-5. Epub 2025 Aug 21. |
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| Placebo | Dietary Supplement | Softgel containing only excipients. 4 soft-gels to be taken daily |
|
| 4-weeks |
| Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA) | 4-weeks |
| Change from baseline in Resting Metabolic Rate (RMR) | 4-weeks |
| Change from baseline in maximal muscle strength during 1-repetition maximum leg press | 4-weeks |
| change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO) | only in sub-elite runners | 4-weeks |
| Change in acylcarnitines levels via metabolomics in plasma | 4-weeks |
| change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only) | 4-weeks |
| change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only) | 4-weeks |
| change in plasma levels of Urolithin A | 4-weeks |
| change in plasma levels of inflammatory marker CRP | 4-weeks |