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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
Sponsor:
Information provided by (Responsible Party):
Tore B. Stage, University of Southern Denmark

Brief Summary:
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: St John's wort Phase 1

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: St John's wort

Subjects will undergo 3 oral glucose tolerance tests:

  1. Without taking any St John's wort
  2. After 3 weeks pretreatment with St John's wort
  3. Minimum 6 weeks after last St John's wort ingestion
Other: St John's wort



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. St John's wort pharmacokinetics [ Time Frame: At time=0 ]
    At time=0, the concentration of active components hypericin and hyperforin will be measured.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 years
  • Males
  • Fasting plasma-glucose < 7.0 mmol/L
  • Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
  • Body mass index < 30 kg/m^2

Exclusion Criteria:

  • Hypersensitivity to St John's wort
  • Chronical or daily alcohol abuse
  • Known liver disease
  • Ingestion of drugs requiring prescription, except locally acting drugs

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): NCT01921881


Locations
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Denmark
Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Odense C, Denmark, DK-5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
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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

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Responsible Party: Tore B. Stage, MSc Pharm, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01921881     History of Changes
Other Study ID Numbers: AKF-385
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Keywords provided by Tore B. Stage, University of Southern Denmark:
Glucose tolerance