- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021341
Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia (BBD)
August 24, 2021 updated by: Lindenwood University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Lindenwood University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Maltodextrin
|
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.
|
Active Comparator: Berberine
500 mg of 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.
|
Active Comparator: Dihydroberberine 200
200 mg of Dihydroberberine
|
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.
|
Active Comparator: Dihydroberberine 100
100 mg of Dihydroberberine
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berberine
Time Frame: 30 days
|
Changes in plasma berberine levels after supplementing 500 mg of berberine
|
30 days
|
Dihydroberberine 200
Time Frame: 30 days
|
Changes in plasma berberine levels after supplementing 200 mg of dihyrdoberberine
|
30 days
|
Dihydroberberine 100
Time Frame: 30 days
|
Changes in plasma berberine levels after supplementing 100 mg of dihyrdoberberine
|
30 days
|
Glucose
Time Frame: 30 days
|
Changes in plasma glucose levels after supplementing either berberine or dihyrdoberberine
|
30 days
|
Insulin
Time Frame: 30 days
|
Changes in insulin levels after supplementing either berberine or dihyrdoberberine
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Kerksick, PhD, Lindenwood University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2020
Primary Completion (Actual)
November 4, 2020
Study Completion (Actual)
November 4, 2020
Study Registration Dates
First Submitted
July 1, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- IRB-20-173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Researchers do not plan to share data to other/outside researchers.
Upon study completion, a manuscript will be developed and submitted for publication.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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