Metabolic Differences Between Dihydroberberine and Micellar Berberine

NCT ID: NCT06202157

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Phase I and Phase II Metabolites of Berberine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LMB (LipoMicel Berberine)

Group Type EXPERIMENTAL

LMB

Intervention Type 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.

DHB (Dihydroberberine)

Group Type EXPERIMENTAL

DHB

Intervention Type 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.

Interventions

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LMB

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.

Intervention Type OTHER

DHB

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.

Intervention Type OTHER

Other Intervention Names

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LipoMicel Berberine Dihydroberberine

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isura

OTHER

Sponsor Role collaborator

Factors Group of Nutritional Companies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ISURA

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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RR401

Identifier Type: -

Identifier Source: org_study_id

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