Metabolic Differences Between Dihydroberberine and Micellar Berberine

N/ACompletedNCT06202157

Factors Group of Nutritional Companies Inc.9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Phase I and Phase II Metabolites of Berberine

Interventions

LMBOTHER

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.

DHBOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ISURA

Burnaby, British Columbia, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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