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

Phase 1CompletedNCT01921881

University of Southern Denmark10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

St John's wortOTHER

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Odense C, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion

Secondary Outcomes

St John's wort pharmacokinetics

At time=0, the concentration of active components hypericin and hyperforin will be measured.

Time frame: At time=0

Other metabolic markers

C-peptide and serum insulin will also be measured during the oral glucose tolerance test.

Time frame: At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion

Data from ClinicalTrials.gov

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