ISURA
Burnaby, British Columbia, V3N 4S9, Canada
Completed
NCT Number: NCT06202157
Metabolic Differences Between Dihydroberberine and Micellar Berberine
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.
Completed
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Notify MeKey information
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
LMB
OtherA 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.
Other names: LipoMicel Berberine
DHB
OtherA 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.
Other names: Dihydroberberine
Primary outcomes
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AUC: the area under the concentration-time curve
Time frame: 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
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Factors Group of Nutritional Companies Inc.
Industry
Collaborators
- Isura
Registry information
Official study title
Metabolic Differences Between Dihydroberberine and Micellar Berberine in Humans
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Jan 11, 2024
- Registry last updated
- Jan 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.