The NutriNet-Santé Study

July 22, 2021 updated by: Mathilde Touvier, University of Paris 13

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

170000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Seine Saint Denis
      • Bobigny, Seine Saint Denis, France, 93017
        • Recruiting
        • EREN
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • aged over 15 years
  • access to internet

Exclusion Criteria:

  • aged under 15 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
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
every 6 months after registration, up to 10 years of follow-up
quality of life using the SF-36 questionnaire
Time Frame: every 6 months after registration, up to 10 years of follow-up
self reported
every 6 months after registration, up to 10 years of follow-up
Weight using anthropometric questionnaire
Time Frame: every year after registration, up to 10 years of follow-up
self reported
every year after registration, up to 10 years of follow-up
Height using anthropometric questionnaire
Time Frame: every year after registration, up to 10 years of follow-up
self reported
every year after registration, up to 10 years of follow-up
Mortality
Time Frame: continuously updated
CepiDC exhaustive national registry
continuously updated
Mental health (incl. anxious disorders, sleep disorders, addictive behaviors, eating disorders)
Time Frame: repeatedly during followup
self reported though validated scales and/or questionnaires
repeatedly during followup
SARSCOV-2 (Covid 19) infection
Time Frame: regular update for a subsampe of the cohort from 2020
serology + questionnaires on symptoms
regular update for a subsampe of the cohort from 2020
multi-morbidity (mental and physical health)
Time Frame: continuous update
combination of previsously listed mental and physical health outcomes
continuous update

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 13

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Conservatoire national des Arts et Métiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2009

Primary Completion (Anticipated)

May 11, 2029

Study Completion (Anticipated)

May 11, 2029

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NutriNet-Santé

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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