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A 30-Day Randomized Crossover Human Study on the Safety and Tolerability of a New Micellar Berberine Formulation with Improved Bioavailability
Metabolites
2025
15(4):240
Bibliography
- PubMed
- PMID 40278369
- PubMed Central
- PMC12028944
- Funding
- The authors reported no external funding; the LipoMicel trademark belongs to Natural Factors Group.
- Competing interests
- Disclosures include ISURA employment/advisory roles, Factors Group ownership and formulation patent interests.
Study snapshot
| Design | Double-blind placebo-controlled randomized crossover safety study |
|---|---|
| Model | Human participants; see population |
| Sample | 19 healthy participants |
| Intervention | Berberine LipoMicel formulation 1000 mg/day versus placebo |
| Duration | 30-day periods with at least 4-week washout |
| Endpoints | Plasma exposure and pharmacokinetics; Drug interaction measurements; Short-term tolerability |
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