- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100774
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Marseille, France, 13005
- Centre d'Investigation Clinique de l'hôpital de la Conception
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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healthy male adults
no added micronutrient, tomato puree, lutein supplement, vitamin E supplement, vitamin D supplement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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micronutrient concentration in plasma chylomicrons
Time Frame: 8 hours
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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.
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8 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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micronutrient concentration in adipose tissue
Time Frame: 8 hours
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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.
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8 hours
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Patrick Borel, PhD, INRA/INSERM/Aix-Marseille University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Zumaraga MP, Desmarchelier C, Gleize B, Nowicki M, Ould-Ali D, Landrier JF, Borel P. Identification of Genetic Polymorphisms Associated with Interindividual Variability of Vitamin A Concentration in Adipose Tissue of Healthy Male Adults. J Nutr. 2024 Dec;154(12):3693-3703. doi: 10.1016/j.tjnut.2024.10.035. Epub 2024 Oct 21.
- Zumaraga MP, Desmarchelier C, Gleize B, Nowicki M, Ould-Ali D, Borel P. Characterization of the interindividual variability of lutein and zeaxanthin concentrations in the adipose tissue of healthy male adults and identification of combinations of genetic variants associated with it. Food Funct. 2024 Sep 30;15(19):9995-10006. doi: 10.1039/d4fo03087g.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2008-A00955-50
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