Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

Not Applicable

Completed

• Conditions: Glycemia
• Interventions: Dietary Supplement: Berberine; Dietary Supplement: Placebo; Dietary Supplement: Dihydroberberine 200; Dietary Supplement: Dihydroberberine 100

• Registration Number: NCT05021341
• Lead Sponsor: Lindenwood University

Brief Summary

The purpose of this study is to determine the bioavailability of berberine and dihydroberberine and their impact on changes in plasma concentrations of glucose and insulin.

Detailed Description

Once determined eligible and provided consent, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion. Eligible study participants will complete one of four testing conditions. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of six venous blood samples. Follow-up blood samples will be collected at 20, 40, 60, 90, and 120 minutes. All collected samples will be collected into two, 4mL EDTA tubes and have aliquots of 600 ul of plasma isolated and frozen at -80 degrees celsius. Collected plasma will be analyzed for changes in berberine, glucose, and insulin. Participants will observe a minimum of 72 hours washout between conditions

Study Timeline

• Study Start: 2020-06-22
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Study First Submitted: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• All participants will be between the ages of 18-45 years.
• Participants will be healthy and free of disease as determined by evaluation of a medical history
• Body mass index (BMI) between 18.5 - 30 kg/m^2

Exclusion Criteria

• Those individuals less than 18 and greater than 45 years of age will be excluded.
• Participants younger than 18 are excluded due to necessity of parental consent.
• Participants greater than 45 years old lie outside of the target demographic for the current study.
• As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder.
• Additional exclusion criteria include: participants with a fasting capillary blood glucose level > 100 mg/dL.
• Current smokers (including vaping) or have quit within the past six months.
• Any over-the-counter or prescription drugs and/or dietary supplements that are known or are purported to impact glycemia and insulinemia.
• Currently or have been following with the past 30 days a ketogenic or very-low carbohydrate diet.
• Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Berberine	Berberine	500 mg of Berberine
Placebo	Placebo	Maltodextrin
Dihydroberberine 200	Dihydroberberine 200	200 mg of Dihydroberberine
Dihydroberberine 100	Dihydroberberine 100	100 mg of Dihydroberberine

Primary Outcome Measures

Name	Time	Method
Dihydroberberine 100	30 days	Changes in plasma berberine levels after supplementing 100 mg of dihyrdoberberine
Insulin	30 days	Changes in insulin levels after supplementing either berberine or dihyrdoberberine
Dihydroberberine 200	30 days	Changes in plasma berberine levels after supplementing 200 mg of dihyrdoberberine
Berberine	30 days	Changes in plasma berberine levels after supplementing 500 mg of berberine
Glucose	30 days	Changes in plasma glucose levels after supplementing either berberine or dihyrdoberberine

Trial Locations

Locations (1)

Lindenwood University; 🇺🇸 Saint Charles, Missouri, United States