Biological Availability of Vitamins and MicronutrientsVITAGENESNCT02100774
Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability
An observational study of Biological Availability of Vitamins and Micronutrients, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability of Vitamins and Micronutrients
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy male adults.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique de l'hôpital de la Conception
Marseille, 13005
About this study
Official title: Effect of Genetic Variants of Intestinal Transporters of Lipophilic Micronutrients (Vitamins D, E and Carotenoids) on Absorption Efficiency of These Compounds.
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).
Read the 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.
- Keywords
- bioavailability, postprandial period, genetic variants, single nucleotide polymorphisms, vitamin, carotenoid, lutein, lycopene, tocopherol, cholecalciferol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy male adults | no added micronutrient, tomato puree, lutein supplement, vitamin E supplement, vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Secondary outcomes (1)
micronutrient concentration in adipose tissue
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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Biological Availability of Vitamins and MicronutrientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Marseille
- Responsible party
- Principal investigator, Patrick Borel, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Patrick Borel, PhD, Study director, INRA/INSERM/Aix-Marseille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100774
- Sponsor's protocol ID
- 2008-A00955-50
- Acronym
- VITAGENES
- Status last verified
- Mar 2014
- First submitted
- 27 Mar 2014
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21957063Borel P, Zumaraga MP, Desmarchelier C. Genetic Determinants of Interindividual Differences in Provitamin A Carotenoid Concentrations in Human Adipose Tissue. Mol Nutr Food Res. 2026 Jul;70(14):e70557. doi: 10.1002/mnfr.70557.
PubMed 42504493Zumaraga MP, Borel P, Desmarchelier C. Genetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males. Food Funct. 2026 Apr 14;17(7):3148-3160. doi: 10.1039/d5fo05171a.
PubMed 41848742Sani L, Astier J, Ould-Ali D, Borel P, Landrier JF. Tomato Puree Enrichment in a High-Fat Meal Reduces Postprandial Plasma and Adipose Tissue Inflammation Biomarkers in Healthy Male Adults: A Crossover Randomized Controlled Trial. Mol Nutr Food Res. 2025 Jul;69(13):e70115. doi: 10.1002/mnfr.70115. Epub 2025 May 12.
PubMed 40351054Zumaraga 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.
PubMed 39442757Zumaraga 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.
PubMed 39279719Desmarchelier 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.
PubMed 27798339Borel 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.
PubMed 26063065Borel 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.
PubMed 24808487
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Variants of Intestinal Transporters of Lipophilic Micronutrients (Vitamins D, E and Carotenoids) on Absorption Efficiency of These Compounds.
- ClinicalTrials.gov ID
- NCT02100774
- Acronym / sponsor ID
- VITAGENES / 2008-A00955-50
- Keywords
- bioavailability, postprandial period, genetic variants, single nucleotide polymorphisms, vitamin, carotenoid, lutein, lycopene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Marseille
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy male adults | – | –no added micronutrient, tomato puree, lutein supplement, vitamin E supplement, vitamin D supplement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy male adults.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
micronutrient concentration in plasma chylomicrons
Time frame: 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.
1 secondary outcome
micronutrient concentration in adipose tissue
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 21957063Borel 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.
- Derived from this study: PubMed 42504493Borel P, Zumaraga MP, Desmarchelier C. Genetic Determinants of Interindividual Differences in Provitamin A Carotenoid Concentrations in Human Adipose Tissue. Mol Nutr Food Res. 2026 Jul;70(14):e70557. doi: 10.1002/mnfr.70557.
- Derived from this study: PubMed 41848742Zumaraga MP, Borel P, Desmarchelier C. Genetic determinants of lycopene concentration in subcutaneous adipose tissue: insights into interindividual variability in adult males. Food Funct. 2026 Apr 14;17(7):3148-3160. doi: 10.1039/d5fo05171a.
- Derived from this study: PubMed 40351054Sani L, Astier J, Ould-Ali D, Borel P, Landrier JF. Tomato Puree Enrichment in a High-Fat Meal Reduces Postprandial Plasma and Adipose Tissue Inflammation Biomarkers in Healthy Male Adults: A Crossover Randomized Controlled Trial. Mol Nutr Food Res. 2025 Jul;69(13):e70115. doi: 10.1002/mnfr.70115. Epub 2025 May 12.
- Derived from this study: PubMed 39442757Zumaraga 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.
- Derived from this study: PubMed 39279719Zumaraga 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.
- Derived from this study: PubMed 27798339Desmarchelier 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.
- Derived from this study: PubMed 26063065Borel 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.
- Derived from this study: PubMed 24808487Borel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Borel, PhD study director
INRA/INSERM/Aix-Marseille University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Availability of Vitamins and Micronutrients, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
micronutrient concentration in plasma chylomicrons (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100774, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.