Phase I and Phase II Metabolites of Berberine
Conditions
Keywords
metabolites, berberine, micellar, dihydroberberine, pharmacokinetics
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.
Interventions
OTHERLMB
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.
OTHERDHB
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.
Sponsors
Isura
Factors Group of Nutritional Companies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Canada
Outcome results
None listed