Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

NCT05021341 | Completed

• 1 other identifier: IRB-20-173
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemia

Outcome Measures

Primary Outcomes (5)

• Berberine

  Changes in plasma berberine levels after supplementing 500 mg of berberine

  30 days

• Dihydroberberine 200

  Changes in plasma berberine levels after supplementing 200 mg of dihyrdoberberine

  30 days

• Dihydroberberine 100

  Changes in plasma berberine levels after supplementing 100 mg of dihyrdoberberine

  30 days

• Glucose

  Changes in plasma glucose levels after supplementing either berberine or dihyrdoberberine

  30 days

• Insulin

  Changes in insulin levels after supplementing either berberine or dihyrdoberberine

  30 days

Study Arms (4)

Berberine

ACTIVE COMPARATOR

500 mg of Berberine

Dietary Supplement: Berberine

Dihydroberberine 200

ACTIVE COMPARATOR

200 mg of Dihydroberberine

Dietary Supplement: Dihydroberberine 200

Dihydroberberine 100

ACTIVE COMPARATOR

100 mg of Dihydroberberine

Dietary Supplement: Dihydroberberine 100

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Berberine DIETARY_SUPPLEMENT

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.

Berberine

Dihydroberberine 200 DIETARY_SUPPLEMENT

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 200

Dihydroberberine 100 DIETARY_SUPPLEMENT

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.

Dihydroberberine 100

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lindenwood University: lead
• NNB Nutrition: collaborator

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Berberine

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chad Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, crossover study design

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 25, 2021
• Study Start: June 22, 2020
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)