Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
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|ClinicalTrials.gov Identifier: NCT01921881|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: St John's wort||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: St John's wort
Subjects will undergo 3 oral glucose tolerance tests:
Other: St John's wort
- Glucose area under curve (AUC) 0-2 hours [ Time Frame: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion ]At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion.
- St John's wort pharmacokinetics [ Time Frame: At time=0 ]At time=0, the concentration of active components hypericin and hyperforin will be measured.
- Other metabolic markers [ Time Frame: At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion ]C-peptide and serum insulin will also be measured during the oral glucose tolerance test.
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): NCT01921881
|Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark|
|Odense C, Denmark, DK-5000|
|Study Director:||Kim Brøsem, Professor, MD||University of Southern Denmark|
|Principal Investigator:||Per Damkier, MD PhD||University of Southern Denmark|
|Principal Investigator:||Tore B. Stage, MSc Pharm||University of Southern Denmark|