The NutriNet-Santé Study

Exercise Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335644
• Other study ID #: NutriNet-Santé
• Status: Recruiting
• Start date: May 11, 2009
• Est. completion date: May 11, 2029

Study information

• Verified date: July 2021
• Source: University of Paris 13
• Contact: Mathilde Touvier, Dr
• Phone: +33148388933
• Email: m.touvier[@]eren.smbh.univ-paris13.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170000
• Est. completion date: May 11, 2029
• Est. primary completion date: May 11, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• aged over 15 years
• access to internet

Exclusion Criteria:

• aged under 15 years

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	EREN	Bobigny	Seine Saint Denis

Sponsors (4)

Lead Sponsor	Collaborator
University of Paris 13	Conservatoire national des Arts et Métiers, Institut National de la Recherche Agronomique, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Hercberg S, Castetbon K, Czernichow S, Malon A, Mejean C, Kesse E, Touvier M, Galan P. The Nutrinet-Santé Study: a web-based prospective study on the relationship between nutrition and health and determinants of dietary patterns and nutritional status. BM — View Citation

Outcome

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

External Links

•   PubMed abstract
•   Scalable listing of all the questionnaires sent to the participants