Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability

NCT ID: NCT02100774

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biological Availability of Vitamins and Micronutrients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy male adults

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University of Marseille

OTHER

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patrick Borel

INRAE Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick Borel, PhD

Role: STUDY_DIRECTOR

INRA/INSERM/Aix-Marseille University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21957063 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39442757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39279719 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27798339 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26063065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24808487 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-A00955-50

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Food or Supplemental Lutein Absorption
NCT04786392 WITHDRAWN PHASE1
Lycopene in Healthy Male Participants
NCT00450957 COMPLETED PHASE1