Metabolic Differences Between Dihydroberberine and Micellar Berberine

NCT06202157 | Completed

• 1 other identifier: RR401
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Phase I and Phase II Metabolites of Berberine

Keywords

metabolites; berberine; micellar; dihydroberberine; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• AUC: the area under the concentration-time curve

  For each berberine metabolite, PK parameters such as Area Under Curve (AUC) of the blood concentrations over a 24-hour period are reported.

  at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.

• Cmax: the maximum blood concentration

  For each berberine metabolite, PK parameters such as the maximum blood concentration (Cmax) are reported.

  at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.

• Tmax: the time at which Cmax is reached

  For each berberine metabolite, PK parameters such as Tmax, the time at which Cmax is reached, are reported.

  at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.

Study Arms (2)

LMB (LipoMicel Berberine)

EXPERIMENTAL

Other: LMB

DHB (Dihydroberberine)

EXPERIMENTAL

Other: DHB

Interventions

LMB OTHER

A baseline blood sample (t=0) is collected from each participant prior to the intervention (LMB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.

Also known as: LipoMicel Berberine

LMB (LipoMicel Berberine)

DHB OTHER

A baseline blood sample (t=0) is collected from each participant prior to the intervention (DHB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.

Also known as: Dihydroberberine

DHB (Dihydroberberine)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 or older
• healthy, good physical condition

You may not qualify if:

• 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

Sponsors & Collaborators

• Factors Group of Nutritional Companies Inc.: lead
• Isura: collaborator

Study Sites (1)

ISURA

Burnaby, British Columbia, V3N 4S9, Canada

Location

MeSH Terms

Interventions

dihydroberberine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)