Status:

COMPLETED

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

Lead Sponsor:

Factors Group of Nutritional Companies Inc.

Conditions:

Pharmacokinetics

Eligibility:

All Genders

21-65 years

Phase:

NA

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 (...

Eligibility Criteria

Inclusion

  • Age 21-65
  • healthy, good physical condition

Exclusion

  • 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

Key Trial Info

Start Date :

February 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 4 2022

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT05370261

Start Date

February 1 2022

End Date

May 4 2022

Last Update

February 13 2023

Active Locations (1)

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1

ISURA

Burnaby, British Columbia, Canada, V3N4S9