Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability (VITAGENES)

Effect of Genetic Variants of Intestinal Transporters of Lipophilic Micronutrients (Vitamins D, E and Carotenoids) on Absorption Efficiency of These Compounds.

The aim was to identify minor genetic variations (single nucleotide polymorphisms) that explain the interindividual variability in bioavailability of fat soluble micronutrients (fat soluble vitamins and carotenoids).

Study Overview

Detailed Description

Healthy male volunteers were genotyped and submitted to 5 test-meals containing either no micronutrient of interest, 100 g tomato puree as a source of carotenoids, a lutein supplement, a vitamin E supplement or a vitamin D supplement. Blood samples were taken in the postprandial period (up to 8 hours after the test-meals intake) and the concentration of the studied micronutrients were measured in the chylomicrons. Multivariate analysis were then performed to identify single nucleotide polymorphisms that best explained the variance in the interindividual response (0 to 8 h area under the curve) in micronutrients.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13005
        • Centre d'Investigation Clinique de l'hôpital de la Conception

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

healthy male adults.

Description

Inclusion Criteria:

gender : male age : 18 to 60 years old BMI: [18 to 29.9] kg/m2 Fasting Cholesterol concentration : < 2,5 g/l Fasting triglyceride concentration < 2 g/l Fasting glycemia ≤ 1,1 g/l Fasting Hemoglobin < 13 g/dl HIV as well as hepatitis C and B negative

Exclusion Criteria:

smokers regular consumption of vitamin supplement > 140 g/week alcohol vegetarian diseases drugs assumed to affect the metabolism of lipids or fat soluble micronutrients (e.g. ezetimibe)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy male adults
no added micronutrient, tomato puree, lutein supplement, vitamin E supplement, vitamin D supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micronutrient concentration in plasma chylomicrons
Time Frame: 8 hours
The subjects were submitted to test-meals rich in micronutrients of interest and the ability of each subject to absorb the studied micronutrients was evaluated by measuring the postprandial chylomicron response (0 to 8 h area under the curve of the chylomicron micronutrient concentration) in each micronutrient.
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
micronutrient concentration in adipose tissue
Time Frame: 8 hours
A first sample of adipose tissue was taken before the intake of the test-meal rich in fat soluble micronutrients. A second sample was taken 8 h after the test-meal intake. The aim was to assess whether the consumption of the studied fat soluble micronutrient modified the concentration of this micronutrient in adipose tissue.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimated)

April 1, 2014

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biological Availability of Vitamins and Micronutrients

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