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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921881
• Other study ID #: AKF-385
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2013
• Last updated: February 12, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• St John's wort

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose area under curve (AUC) 0-2 hours	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	Yes
Secondary	St John's wort pharmacokinetics	At time=0, the concentration of active components hypericin and hyperforin will be measured.	At time=0	No
Secondary	Other metabolic markers	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	No