Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels

February 9, 2023 updated by: Factors Group of Nutritional Companies Inc.

Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels

The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.

As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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, V3N4S9
        • 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

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21-65
  • healthy, good physical condition

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Gastrointestinal conditions
  • Acute or chronic liver disease
  • Acute or chronic kidney disease
  • Acute or chronic cardiovascular disease
  • Hematological disease
  • Diabetes
  • Allergy or Intolerance to gluten
  • Allergy or Intolerance to Berberine
  • Use of any form of nicotine or tobacco
  • Alcohol and substance abuse history
  • Use of medications (e.g., blood sugar-lowering agents, or statins)
  • Use of Berberine supplements
  • 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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Berberine LipoMicel soft-gel

Each participant receives their treatment of Berberine LipoMicel soft-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.

Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing.

Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used.

Adverse events are recorded throughout the study by direct questioning.
Dietary supplement: Berberine LipoMicel
Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine
EXPERIMENTAL: Regular Berberine hard-gel

Each participant receives their treatment of regular Berberine hard-gel capsules at a total dose of 500 mg berberine. Treatments are consumed with a glass of water (approx. 200 mL), and standardized breakfast. A standardized lunch is served after the 4hr fasting; standardized dinner after 8hrs. Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours.

Samples that are not processed the same day are kept frozen at -20°C until further processing and analysis. Processed samples are analyzed by LC-MS within 24 hours after processing.

Participants are asked to arrive after an overnight fast (at least 9hrs). Each participant acts as their own control; there is no separate control group. A washout period of at least 7 days between each treatment will be used.

Adverse events are recorded throughout the study by direct questioning.
Dietary supplement: Regular Berberine hard-gels
Total dose of 500 mg of berberine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC: the area under the concentration-time curve
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Area under the plasma concentration versus time curve (AUC) with that of with free/regular berberine (hydrochloride).
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Cmax: maximum plasma concentration
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the Peak Plasma Concentration (Cmax) with that of with free/regular berberine (hydrochloride).
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Tmax: the time point of maximum plasma concentration
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
To evaluate the gastrointestinal absorption of orally ingested berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing the time point of maximum plasma concentration (Tmax) with that of with free/regular berberine (hydrochloride).
0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on Blood sugar levels
Time Frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
To evaluate the immediate or short-term effects of orally ingested Berberine on blood sugar levels in healthy volunteers by using a glucose tolerance test (OGTT).
0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
Changes in Blood sugar concentrations
Time Frame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
To evaluate changes in blood sugar concentrations of orally ingested Berberine in healthy volunteers by using a portable glucometer.
0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)

Collaborators and Investigators

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

Sponsor

Factors Group of Nutritional Companies Inc.

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)

February 1, 2022

Primary Completion (ACTUAL)

May 4, 2022

Study Completion (ACTUAL)

May 4, 2022

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (ACTUAL)

May 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-08-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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