Metabolic Differences Between Dihydroberberine and Micellar Berberine

Not Applicable

Completed

• Conditions: Phase I and Phase II Metabolites of Berberine
• Interventions: Other: LMB; Other: DHB

• Registration Number: NCT06202157
• Lead Sponsor: Factors Group of Nutritional Companies Inc.

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 samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Age 21 or older
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMB (LipoMicel Berberine)	LMB	-
DHB (Dihydroberberine)	DHB	-

Primary Outcome Measures

Name	Time	Method
AUC: the area under the concentration-time curve	at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.	For each berberine metabolite, PK parameters such as Area Under Curve (AUC) of the blood concentrations over a 24-hour period are reported.
Tmax: the time at which Cmax is reached	at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.	For each berberine metabolite, PK parameters such as Tmax, the time at which Cmax is reached, are reported.
Cmax: the maximum blood concentration	at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.	For each berberine metabolite, PK parameters such as the maximum blood concentration (Cmax) are reported.

Trial Locations

Locations (1)

ISURA; 🇨🇦 Burnaby, British Columbia, Canada