Trials / Completed
CompletedNCT06732908
Safety Profile of a New Berberine Formulation with Improved Bioavailability
Evaluating the Safety and Tolerability of LipoMicel Berberine
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Isura · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is: Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals? Participants will: 1. Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days. 2. Return to study site weekly for blood tests. 3. Keep a diary of their symptoms (collection of adverse events).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | LipoMicel Berberine | Berberine powder in a LipoMicel matrix encapsulated in soft gel. |
| OTHER | Placebo | microcrystalline cellulose |
Timeline
- Start date
- 2024-05-27
- Primary completion
- 2024-08-27
- Completion
- 2024-10-31
- First posted
- 2024-12-13
- Last updated
- 2024-12-13
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06732908. Inclusion in this directory is not an endorsement.