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The Absorption of Bioactive Berberine in Human

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438292
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Florida High Tech Corridor Council
Designs for Health, Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Berberine from medicinal plants has therapeutic activities against multiple chronic diseases. But its absorption rate is very low. The objective of this study is to test if adding TPGS or Quillaja extract as an emulsifier enhance the absorption of berberine in human.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Berberine Dietary Supplement: TPGS emulsified berberine Dietary Supplement: Quillaja extract emulsified berberine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: To Test the Efficacy of Novel Berberine Emulsification by TPGS or Quillaja Extract on the Absorption of Berberine Compared to Berberine Powder in Humans
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : September 11, 2020
Actual Study Completion Date : September 11, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Quillaja

Arm Intervention/treatment
Experimental: Group A - TPGS emulsified with berberine
After an 8-10 hour overnight fast, Group A will receive two soft capsules of TPGS (400mg) emulsified berberine. Following a 7 day wash out period, Group A participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Following another 7 day wash out period, Group A participants will then receive two hard shell capsules of the berberine reference powder 400mg. Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.
Dietary Supplement: Berberine
Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Dietary Supplement: TPGS emulsified berberine
Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.
Other Name: Berb-Evail

Dietary Supplement: Quillaja extract emulsified berberine
Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

Experimental: Group B - Quillaja extract emulsified with Berberine
After an 8-10 hour overnight fast, Group B will receive four soft capsules of Quillaja extract emulsified berberine (400mg). Following a 7 day wash out period, Group B participants will then receive two hard shell capsules of the berberine reference powder (400mg). Following another 7 day wash out period, Group B participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.
Dietary Supplement: Berberine
Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Dietary Supplement: TPGS emulsified berberine
Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.
Other Name: Berb-Evail

Dietary Supplement: Quillaja extract emulsified berberine
Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

Experimental: Group C - Berberine reference powder
After an 8-10 hour overnight fast, Group C will receive two hard shell capsules of the berberine reference powder (400mg). Following a 7 day wash out period, Group C participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Following another 7 day wash out period, Group C participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.
Dietary Supplement: Berberine
Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Dietary Supplement: TPGS emulsified berberine
Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.
Other Name: Berb-Evail

Dietary Supplement: Quillaja extract emulsified berberine
Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.




Primary Outcome Measures :
  1. AUC:the area under the concentration-time curve [ Time Frame: Pre-dose, Hour 0.5, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8 and Hour 12 ]
    To determine change in bioavailability of orally ingested berberine in human volunteers by increasing the area under the concentration-time curve (AUC).

  2. Cmax: maximum plasma concentration [ Time Frame: Pre-dose, Hour 0.5, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8 and Hour 12 ]
    To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its plasma concentration peak concentration (Cmax).

  3. Tmax: the time point of maximum plasma concentration [ Time Frame: Pre-dose, Hour 0.5, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8 and Hour 12 ]
    To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its the time point of maximum plasma concentration (Tmax).


Secondary Outcome Measures :
  1. Changes in concentrations of berberine metabolites. [ Time Frame: Pre-dose, Hour 0.5, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8 and Hour 12 ]
    To determine change in berberine metabolites concentrations.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Normal BMI (20-27)

Exclusion Criteria:

  • Pregnancy
  • Gastro-intestinal conditions
  • Diabetics,
  • Alcohol and substance abuse history,
  • Allergy to berberine,
  • Current berberine use,
  • Use of H2 blockers, proton pump inhibitors, blood sugar-lowering agents, or statins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438292


Locations
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United States, Florida
Food Science and human nutrition department at University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Florida High Tech Corridor Council
Designs for Health, Inc.
Investigators
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Principal Investigator: Liwei Gu, PhD Univerisity of Florida
Study Director: Yavuz Yagiz, PhD Univerisity of Florida
Study Director: Gary P Wang, MD PhD, FIDSA Univerisity of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03438292    
Other Study ID Numbers: IRB201800017
OCR17000 ( Other Identifier: University of Florida )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Berberine
TPGS
Pharmacokinetics
Human intervention study
Quillaja extract