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The NutriNet-Santé Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335644
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Conservatoire national des Arts et Métiers
Information provided by (Responsible Party):
Mathilde Touvier, University of Paris 13

Tracking Information
First Submitted Date October 11, 2017
First Posted Date November 8, 2017
Last Update Posted Date March 25, 2020
Actual Study Start Date May 11, 2009
Estimated Primary Completion Date May 11, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • quality of life using the SF-36 questionnaire [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported
  • Weight using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported
  • Height using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The NutriNet-Santé Study
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
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=170 000 as of 2020) 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

Detailed Description NutriNet-Santé is a large-scale (n=170,000) 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: 3,800 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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).
Condition
  • Diet, Food, and Nutrition
  • Exercise
  • Diseases Category
  • Cohort Studies
  • Adult
  • Anthropometry
  • Humans
  • Internet
  • Surveys and Questionnaires
  • Mortality
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 23, 2020)
170000
Original Estimated Enrollment
 (submitted: November 2, 2017)
160000
Estimated Study Completion Date May 11, 2029
Estimated Primary Completion Date May 11, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • aged over 15 years
  • access to internet

Exclusion Criteria:

  • aged under 15 years
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mathilde Touvier, Dr +33148388933 m.touvier@eren.smbh.univ-paris13.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03335644
Other Study ID Numbers NutriNet-Santé
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mathilde Touvier, University of Paris 13
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
Investigators Not Provided
PRS Account University of Paris 13
Verification Date March 2020