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

December 9, 2024 updated by: Isura

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V3N 4T5
        • ISURA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Berberine LipoMicel
1000 mg of LipoMicel Berberine (2 soft gel capsules) administered daily to randomized healthy participants for 30 days.
Dietary supplement: LipoMicel Berberine
Berberine powder in a LipoMicel matrix encapsulated in soft gel.
Placebo Comparator: Placebo
Placebo capsules containing microcrystalline cellulose administered daily to randomized healthy participants for 30 days.
Other: Placebo
microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of LipoMicel Berberine - ALT
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on ALT.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of Lipomicel Berberine - AST
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on AST.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Bilirubin
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in liver function based on bilirubin.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Serum creatinine
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on serum creatinine.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Glomerular filtration rate (GFR)
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in kidney function based on GFR.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Fasting blood glucose
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in blood glucose levels based on fasting blood glucose.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Total cholesterol (TC)
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TC.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Low-density lipoprotein (LDL) cholesterol
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on LDL.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - High-density lipoprotein (HDL) cholesterol
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on HDL.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
Safety of LipoMicel Berberine - Triglycerides (TG)
Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)
To evaluate changes in lipid profile based on TG.
0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of Treatment: Bloating
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Constipation
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Diarrhea
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Heartburn
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: cramps
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: knotted feeling in abdomen
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Rash
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Nausea
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Dizziness
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Blurred vision
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days
Tolerability of Treatment: Other (unrelated to treatment)
Time Frame: From enrollment to the end of treatment at 30 days
To evaluate tolerability via the collection of health questionnaires. Participants report severity criteria of None, Mild, Moderate, Severe, or Life-threatening.
From enrollment to the end of treatment at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isura

Investigators

  • Principal Investigator: Julia Solnier, PhD, ISURA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Actual)

August 27, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-11-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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