Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia
Condition: Glycemia
Study type: Interventional

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
    

Intervention name(s): Berberine; Dihydroberberine 200; Dihydroberberine 100; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, crossover study design
Masking: Double (Participant, Investigator)
Primary purpose: Other