Clinical trial NCT05021341: Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia
Official title: Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemia
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: NNB Nutrition
First posted: 2021-08-25
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, crossover study design
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Berberine
timeFrame: 30 days
measure: Dihydroberberine 200
timeFrame: 30 days
measure: Dihydroberberine 100
timeFrame: 30 days
measure: Glucose
timeFrame: 30 days
measure: Insulin
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Lindenwood University
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: