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Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake | Experimental | Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure | Dietary Supplement | Fruit flavored sachet containing fixed dose of Mitopureâ„¢ (Proprietary Urolithin A) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure/rejection rate (% of the samples) collected at home by participants. | Acceptability target goal is to hit 80% of analyzed samples | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots. | 4 weeks | |
| Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Faitg, PhD | Contact | +41215521272 | jfaitg@amazentis.com |
| Name | Affiliation | Role |
|---|---|---|
| Anurag Singh, MD, PhD | Amazentis SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amazentis USA | Recruiting | San Francisco | California | 94111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34117375 | Background | Singh A, D'Amico D, Andreux PA, Dunngalvin G, Kern T, Blanco-Bose W, Auwerx J, Aebischer P, Rinsch C. Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. Eur J Clin Nutr. 2022 Feb;76(2):297-308. doi: 10.1038/s41430-021-00950-1. Epub 2021 Jun 11. |
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| Pomegranate Juice | Dietary Supplement | 100% Pomegranate juice |
|
| 4 weeks |
| Validation of a health questionnaire on participants health status | 4 weeks |