Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability

Completed

• Conditions: Biological Availability of Vitamins and Micronutrients

• Registration Number: NCT02100774
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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).

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2010-07
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Study First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
micronutrient concentration in plasma chylomicrons	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.

Secondary Outcome Measures

Name	Time	Method
micronutrient concentration in adipose tissue	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.

Trial Locations

Locations (1)

Centre d'Investigation Clinique de l'hôpital de la Conception; 🇫🇷 Marseille, France