Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

Glycemia Clinical Trial

— BBD  

Official title:

Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021341
• Other study ID #: IRB-20-173
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: November 4, 2020

Study information

• Verified date: August 2021
• Source: Lindenwood University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glycemia

Intervention

Dietary Supplement:
• Berberine
For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (500 mg of berberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
• Dihydroberberine 200
For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (200 mg of dihydroberberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
• Dihydroberberine 100
For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (100 mg of dihydroberberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
• Placebo
For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (Maltodextrin placebo) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.

Locations

Country	Name	City	State
United States	Lindenwood University	Saint Charles	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Lindenwood University	NNB Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berberine	Changes in plasma berberine levels after supplementing 500 mg of berberine	30 days
Primary	Dihydroberberine 200	Changes in plasma berberine levels after supplementing 200 mg of dihyrdoberberine	30 days
Primary	Dihydroberberine 100	Changes in plasma berberine levels after supplementing 100 mg of dihyrdoberberine	30 days
Primary	Glucose	Changes in plasma glucose levels after supplementing either berberine or dihyrdoberberine	30 days
Primary	Insulin	Changes in insulin levels after supplementing either berberine or dihyrdoberberine	30 days