Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals

February 12, 2015 updated by: Tore B. Stage, University of Southern Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, DK-5000
        • Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St John's wort pharmacokinetics
Time Frame: At time=0
At time=0, the concentration of active components hypericin and hyperforin will be measured.
At time=0
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.
At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKF-385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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