Metabolic Differences Between Dihydroberberine and Micellar Berberine

Factors Group of Nutritional Companies

Status: Completed

Conditions: Phase I and Phase II Metabolites of Berberine

Treatments: Other: DHB; Other: LMB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06202157

RR401

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups

LMB (LipoMicel Berberine)

Experimental group

Treatment:

Other: LMB

DHB (Dihydroberberine)

Experimental group

Treatment:

Other: DHB