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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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