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

Not Applicable

Completed

• Conditions: Pharmacokinetics

• Registration Number: NCT05370261
• Lead Sponsor: Factors Group of Nutritional Companies Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUC: the area under the concentration-time curve	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).
Cmax: maximum plasma concentration	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).
Tmax: the time point of maximum plasma concentration	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).

Secondary Outcome Measures

Name	Time	Method
Effects on Blood sugar levels	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).
Changes in Blood sugar concentrations	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.

Trial Locations

Locations (1)

ISURA; 🇨🇦 Burnaby, British Columbia, Canada