Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels
NCT ID: NCT05370261
Last Updated: 2023-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2022-02-01
2022-05-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
Berberine LipoMicel
Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine
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.
Regular Berberine hard-gels
Total dose of 500 mg of berberine
Interventions
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Berberine LipoMicel
Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine
Regular Berberine hard-gels
Total dose of 500 mg of berberine
Eligibility Criteria
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Inclusion Criteria
* healthy, good physical condition
Exclusion Criteria
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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Factors Group of Nutritional Companies Inc.
INDUSTRY
Responsible Party
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Locations
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ISURA
Burnaby, British Columbia, Canada
Countries
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References
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Solnier J, Zhang Y, Kuo YC, Du M, Roh K, Gahler R, Wood S, Chang C. Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers. Pharmaceutics. 2023 Nov 1;15(11):2567. doi: 10.3390/pharmaceutics15112567.
Other Identifiers
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2021-08-004
Identifier Type: -
Identifier Source: org_study_id
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