Clinical trial NCT02100774: Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability
Official title: Effect of Genetic Variants of Intestinal Transporters of Lipophilic Micronutrients (Vitamins D, E and Carotenoids) on Absorption Efficiency of These Compounds.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biological Availability of Vitamins and Micronutrients
Keywords: bioavailability
postprandial period
genetic variants
single nucleotide polymorphisms
vitamin
carotenoid
lutein
lycopene
tocopherol
cholecalciferol
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2014-04-01
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy male adults.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: micronutrient concentration in plasma chylomicrons
timeFrame: 8 hours
Secondary outcomes:
measure: micronutrient concentration in adipose tissue
timeFrame: 8 hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Centre d'Investigation Clinique de l'hôpital de la Conception
Study officials:
affiliation: INRA/INSERM/Aix-Marseille University
name: Patrick Borel, PhD
role: STUDY_DIRECTOR
References:
citation: Borel P. Genetic variations involved in interindividual variability in carotenoid status. Mol Nutr Food Res. 2012 Feb;56(2):228-40. doi: 10.1002/mnfr.201100322. Epub 2011 Sep 29.
citation: Desmarchelier C, Borel P, Goncalves A, Kopec R, Nowicki M, Morange S, Lesavre N, Portugal H, Reboul E. A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Cholecalciferol Bioavailability in Healthy Men. J Nutr. 2016 Dec;146(12):2421-2428. doi: 10.3945/jn.116.237115. Epub 2016 Oct 26.
citation: Borel P, Desmarchelier C, Nowicki M, Bott R. A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Dietary beta-Carotene Bioavailability in Healthy Men. J Nutr. 2015 Aug;145(8):1740-7. doi: 10.3945/jn.115.212837. Epub 2015 Jun 10.
citation: Borel P, Desmarchelier C, Nowicki M, Bott R, Morange S, Lesavre N. Interindividual variability of lutein bioavailability in healthy men: characterization, genetic variants involved, and relation with fasting plasma lutein concentration. Am J Clin Nutr. 2014 Jul;100(1):168-75. doi: 10.3945/ajcn.114.085720. Epub 2014 May 7.