The NutriNet-Santé Study

Sponsor

University of Paris 13 (Other)

Overall Status

Recruiting

CT.gov ID

NCT03335644

Collaborator

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

170,000

Enrollment

Location

240

Anticipated Duration (Months)

708.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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

Anticipated Primary Completion Date :

May 11, 2029

Anticipated Study Completion Date :

May 11, 2029

Outcome Measures

Primary Outcome Measures

cancers using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
CVD using health questionnaire and/or the dedicated website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
type 2 diabetes using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
hypertension using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
metabolic syndrome using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
depression using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
migraine using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
rheumatoid arthritis using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
cognitive decline using health questionnaire and/or the website for declaration of major health events [every 6 months after registration, up to 10 years of follow-up]
self reported
quality of life using the SF-36 questionnaire [every 6 months after registration, up to 10 years of follow-up]
self reported
Weight using anthropometric questionnaire [every year after registration, up to 10 years of follow-up]
self reported
Height using anthropometric questionnaire [every year after registration, up to 10 years of follow-up]
self reported
Mortality [continuously updated]
CepiDC exhaustive national registry
Mental health (incl. anxious disorders, sleep disorders, addictive behaviors, eating disorders) [repeatedly during followup]
self reported though validated scales and/or questionnaires
SARSCOV-2 (Covid 19) infection [regular update for a subsampe of the cohort from 2020]
serology + questionnaires on symptoms
multi-morbidity (mental and physical health) [continuous update]
combination of previsously listed mental and physical health outcomes