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

NCT ID: NCT01921881

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

St John's wort

Intervention Type OTHER

Interventions

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St John's wort

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Tore B. Stage

MSc Pharm

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim Brøsem, Professor, MD

Role: STUDY_DIRECTOR

University of Southern Denmark

Per Damkier, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Tore B. Stage, MSc Pharm

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark

Odense C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AKF-385

Identifier Type: -

Identifier Source: org_study_id

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