Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia (BBD)

Lindenwood University

Status: Completed

Conditions: Glycemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dihydroberberine 200; Dietary Supplement: Berberine; Dietary Supplement: Dihydroberberine 100

Study type: Interventional

Funder types: Other

Identifiers

NCT05021341

IRB-20-173

Details and patient eligibility

About

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.

Full 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

Enrollment: 5 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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5 participants in 4 patient groups, including a placebo group

Berberine

Active Comparator group

Description:

500 mg of Berberine

Treatment:

Dietary Supplement: Berberine

Dihydroberberine 200

Active Comparator group

Description:

200 mg of Dihydroberberine

Treatment:

Dietary Supplement: Dihydroberberine 200

Dihydroberberine 100

Active Comparator group

Description:

100 mg of Dihydroberberine

Treatment:

Dietary Supplement: Dihydroberberine 100

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo