NCT02100774

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
Last Updated

November 21, 2025

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

March 27, 2014

Last Update Submit

November 18, 2025

Conditions

Biological Availability of Vitamins and Micronutrients

Keywords

bioavailabilitypostprandial periodgenetic variantssingle nucleotide polymorphismsvitamincarotenoidluteinlycopenetocopherolcholecalciferol

Outcome Measures

Primary Outcomes (1)

  • micronutrient concentration in plasma chylomicrons

    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 Outcomes (1)

  • micronutrient concentration in adipose tissue

    8 hours

Study Arms (1)

healthy male adults

no added micronutrient, tomato puree, lutein supplement, vitamin E supplement, vitamin D supplement

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy male adults.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique de l'hôpital de la Conception

Marseille, 13005, France

Location

Related Publications (6)

  • 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.

    PMID: 21957063BACKGROUND

  • 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.

    PMID: 39442757DERIVED

  • 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.

    PMID: 39279719DERIVED

  • 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.

    PMID: 27798339DERIVED

  • 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.

    PMID: 26063065DERIVED

  • 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.

    PMID: 24808487DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, adipose tissue

Study Officials

  • Patrick Borel, PhD

    INRA/INSERM/Aix-Marseille University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
INRAE Research Director

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

December 1, 2013

Last Updated

November 21, 2025

Record last verified: 2014-03

Locations

FR(1)