NCT06202157

Metabolic Differences Between Dihydroberberine and Micellar Berberine

Metabolic Differences Between Dihydroberberine and Micellar Berberine in Humans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Factors Group of Nutritional Companies Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: Canada