Vitamin E metabolomics in healthy volunteers

Not Applicable

Recruiting

• Conditions: Metabolism; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12615000752561
• Lead Sponsor: Charles University in Prague

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Healthy adult volunteers, aged 18-65 years, of both sexes will be admitted to the study

Exclusion Criteria

Oral Contraception, pregnancy and/or positive pregnancy test, lactation, participation in other clinical trials currently and/or in the previous 3 months, use of drugs with enzyme-inducing properties during the previous 4 weeks, use of vitamin medicinal products (including OTC) in the previous 4 weeks, active viral infection during the previous 4 weeks, immunization during the previous 4 weeks, alcohol and/or drug abuse history, smoking

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The metabolomic profile change after fortnight vitamin E food suplement. This is one composite outcome.<br>Endogenous metabolome will be obtained using ultra-performance liquid chromatography electrospray ionization time-of-flight mass spectrometry and data analyzed using multivariate analysis tools. [Baseline, and at 7th and 14th day after vitamin E food suplement.]

Secondary Outcome Measures

Name	Time	Method
Verify the effect of pregnane xenobiotic receptor (PXR) polymorphisms on potential changes in metabolomics induced by vitamin E food suplement. PXR polymorhism will be detected using PCR methods.[Blood samples for PXR polymorphisms identification will be taken at baseline.]