Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

June 22, 2020

Primary Completion Date

November 4, 2020

Study Completion Date

November 4, 2020

Conditions
Glycemia
Interventions
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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Trial Locations (1)

63301

Lindenwood University, Saint Charles

All Listed Sponsors
collaborator

NNB Nutrition

UNKNOWN

lead

Lindenwood University

OTHER

NCT05021341 - Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia | Biotech Hunter | Biotech Hunter