Safety Profile of a New Berberine Formulation with Improved Bioavailability

Evaluating the Safety and Tolerability of LipoMicel Berberine

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).

Inclusion Criteria:

• Healthy men or women between 21-65 years of age.
• Completed an online health questionnaire on their medical history
• A voluntarily signed informed consent form.

Exclusion Criteria:

• Use of anti-inflammatory or non-steroidal anti-inflammatory medication
• Presence of cardiovascular disease and/or other acute or chronic diseases (e.g., liver, kidney or gastrointestinal diseases).
• Use of cannabis, nicotine or tobacco
• Drinking of excess alcohol (>20 g/day)
• Those who are or plan to become pregnant
• Use of antioxidant supplements
• Use of cholesterol-lowering agents
• Participation in another investigational study