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Safety Profile of a New Berberine Formulation with Improved Bioavailability

NCT06732908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-12-13

No results posted yet for this study

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

  • Safety

Interventions

DIETARY_SUPPLEMENT

LipoMicel Berberine

Berberine powder in a LipoMicel matrix encapsulated in soft gel.

OTHER

Placebo

microcrystalline cellulose

Sponsors & Collaborators

  • Isura

    lead OTHER

Principal Investigators

  • Julia Solnier, PhD · Isura

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2024-08-27
Completion
2024-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06732908 on ClinicalTrials.gov