Trials / Completed
CompletedNCT03837925
Pharmaco-metabolomic Effects of Statins: METASTATINE
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- French Cardiology Society · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.
Detailed description
The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atorvastatin 40mg Tablet | Patient participation for 6 weeks of treatment |
| DRUG | Placebo comparator | Patient participation for 6 weeks of treatment |
Timeline
- Start date
- 2019-06-13
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
- First posted
- 2019-02-12
- Last updated
- 2023-01-18
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03837925. Inclusion in this directory is not an endorsement.