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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: St John's wort

• Registration Number: NCT01921881
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-13
• Study Start: 2013-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
St John's wort	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

Primary Outcome Measures

Name	Time	Method
Glucose area under curve (AUC) 0-2 hours	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

Name	Time	Method
Other metabolic markers	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.
St John's wort pharmacokinetics	At time=0	At time=0, the concentration of active components hypericin and hyperforin will be measured.

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark; 🇩🇰 Odense C, Denmark