Safety Profile of a New Berberine Formulation with Improved Bioavailability (Berberine Safe)

Isura

Status: Completed

Conditions: Safety

Treatments: Dietary Supplement: LipoMicel Berberine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06732908

2022-11-002

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Berberine LipoMicel

Active Comparator group

Description:

1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days.

Treatment:

Dietary Supplement: LipoMicel Berberine

Placebo

Placebo Comparator group

Description:

Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days.

Treatment:

Other: Placebo