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Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels

NCT05370261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-13

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.

As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.

Conditions

  • Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Berberine LipoMicel

Berberine LipoMicel® soft-gels. Total dose of 500 mg of berberine

DIETARY_SUPPLEMENT

Regular Berberine hard-gels

Total dose of 500 mg of berberine

Sponsors & Collaborators

  • Factors Group of Nutritional Companies Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-05-04
Completion
2022-05-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370261 on ClinicalTrials.gov