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OpenTrials
Completed

NCT Number: NCT01921881

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Odense C, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

St John's Wort

Other

Primary outcomes

  1. Glucose area under curve (AUC) 0-2 hours

    Time frame: 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 outcomes

  1. St John's wort pharmacokinetics

    Time frame: At time=0

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

  2. Other metabolic markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2013
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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