Metabolic Differences Between Dihydroberberine and Micellar Berberine

F

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

9 participants in 2 patient groups

LMB (LipoMicel Berberine)
Experimental group
Treatment:
Other: LMB
DHB (Dihydroberberine)
Experimental group
Treatment:
Other: DHB

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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