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The NutriNet-Santé Study

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ClinicalTrials.gov Identifier: NCT03335644
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : July 26, 2021
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conservatoire national des Arts et Métiers
Information provided by (Responsible Party):
Mathilde Touvier, University of Paris 13

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en


Condition or disease
Diet, Food, and Nutrition Exercise Diseases Category Cohort Studies Adult Anthropometry Humans Internet Surveys and Questionnaires Mortality

Detailed Description:
NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.
Study Design
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Study Type : Observational
Estimated Enrollment : 170000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors
Actual Study Start Date : May 11, 2009
Estimated Primary Completion Date : May 11, 2029
Estimated Study Completion Date : May 11, 2029
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. cancers using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  2. CVD using health questionnaire and/or the dedicated website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  3. type 2 diabetes using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  4. hypertension using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  5. metabolic syndrome using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  6. depression using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  7. migraine using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  8. rheumatoid arthritis using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  9. cognitive decline using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  10. quality of life using the SF-36 questionnaire [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  11. Weight using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported

  12. Height using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported

  13. Mortality [ Time Frame: continuously updated ]
    CepiDC exhaustive national registry

  14. Mental health (incl. anxious disorders, sleep disorders, addictive behaviors, eating disorders) [ Time Frame: repeatedly during followup ]
    self reported though validated scales and/or questionnaires

  15. SARSCOV-2 (Covid 19) infection [ Time Frame: regular update for a subsampe of the cohort from 2020 ]
    serology + questionnaires on symptoms

  16. multi-morbidity (mental and physical health) [ Time Frame: continuous update ]
    combination of previsously listed mental and physical health outcomes


Biospecimen Retention:   Samples With DNA
Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The NutriNet-Santé study is a French ongoing web-based cohort launched in 2009 with the objective to study the associations between nutrition and health as well as the determinants of dietary behaviors and nutritional status. This cohort has been previously described in details (citations). Participants aged over 15 years with access to the Internet are recruited by vast multimedia campaigns. All questionnaires are completed online using a dedicated website (www.etude-nutrinet-sante.fr).
Criteria

Inclusion Criteria:

  • aged over 15 years
  • access to internet

Exclusion Criteria:

  • aged under 15 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335644


Contacts
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Contact: Mathilde Touvier, Dr +33148388933 m.touvier@eren.smbh.univ-paris13.fr

Locations
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France
EREN Recruiting
Bobigny, Seine Saint Denis, France, 93017
Contact: Mathilde Touvier, Dr    +33148388933    m.touvier@eren.smbh.univ-paris13.fr   
Sub-Investigator: Pilar Galan, Dr         
Sub-Investigator: Serge Hercberg, Pr         
Sub-Investigator: Emmanuelle Kesse-Guyot, Dr         
Sub-Investigator: Sandrine Péneau, Dr         
Sub-Investigator: Léopold Fezeu, Dr         
Sub-Investigator: Chantal Julia, Dr         
Sub-Investigator: Valentina Andreeva, Dr         
Sub-Investigator: Allès Benjamin, Dr         
Sub-Investigator: Baudry Julia, Dr         
Sub-Investigator: Deschasaux Mélanie, Dr         
Sponsors and Collaborators
University of Paris 13
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conservatoire national des Arts et Métiers
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mathilde Touvier, Dr, University of Paris 13
ClinicalTrials.gov Identifier: NCT03335644    
Other Study ID Numbers: NutriNet-Santé
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathilde Touvier, University of Paris 13:
determinants of dietary patterns and nutritional status
Food additives, Food processing
Exclusion diets, vegetarian diet, vegan diet
Organic food, pesticide exposure, sustainability
Gut microbiota
Food labeling
Dietary supplements
Food based dietary guidelines
 Psychological determinants of food behavior
Geographical determinants of food behavior
Breastfeeding
Mental health
Cancer
Cardiovascular and cardiometabolic health
Multimorbidity