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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370261
• Other study ID #: 2021-08-004
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: May 4, 2022

Study information

• Verified date: February 2023
• Source: Factors Group of Nutritional Companies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Dietary Supplement:
• Berberine LipoMicel
Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine
• Regular Berberine hard-gels
Total dose of 500 mg of berberine

Locations

Country	Name	City	State
Canada	ISURA	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Factors Group of Nutritional Companies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC: the area under the concentration-time curve	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)
Primary	Cmax: maximum plasma concentration	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)
Primary	Tmax: the time point of maximum plasma concentration	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	Effects on Blood sugar levels	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)
Secondary	Changes in Blood sugar concentrations	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)