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

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: Type 2 Diabetes
• Intervention / Treatment: Other: St John's wort

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: St John's wort; Subjects will undergo 3 oral glucose tolerance tests: Without taking any St John's wort; After 3 weeks pretreatment with St John's wort; 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	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	At time=0, the concentration of active components hypericin and hyperforin will be measured.	At time=0
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

Collaborators and Investigators

• 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

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: Glucose tolerance
• Other Study ID Numbers: AKF-385