Status:
COMPLETED
Metabolic Differences Between Dihydroberberine and Micellar Berberine
Lead Sponsor:
Factors Group of Nutritional Companies Inc.
Collaborating Sponsors:
Isura
Conditions:
Phase I and Phase II Metabolites of Berberine
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood sampl...
Eligibility Criteria
Inclusion
- Age 21 or older
- 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 :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06202157
Start Date
April 1 2023
End Date
December 31 2023
Last Update
January 11 2024
Active Locations (1)
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1
ISURA
Burnaby, British Columbia, Canada, V3N 4S9