Dynamic Mediterranean Prospective Cohort: the SUN Project

Chronic Disease Clinical Trial

Official title:

Dynamic Mediterranean Prospective Cohort: the SUN Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02669602
• Other study ID #: SUN
• Status: Enrolling by invitation
• Start date: December 1999
• Est. completion date: December 2075

Study information

• Verified date: May 2022
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate the associations between nutrition and lifestyle and chronic diseases.

Description:

The SUN Project (University of Navarra Follow-Up Study) began in 1999, and currently more than 20,500 people participate. The Project is permanently open to new volunteers, and around 2,000 new participants are invited each year. A new questionnaire is sent to participants every two years. The questionnaires are named with the letter "Q," followed by the number of years that have passed since the participant first volunteered. The first questionnaire is titled "Q0" and is followed by "Q2","Q4", etc. The cohort is "dynamic" thanks to the fact that it is permanently open to new volunteers. Although the Project was created by the Department of Preventive Medicine and Public Health of the University of Navarra, it now counts on the invaluable collaboration of other Spanish university centers. Thanks to the invaluable collaboration of our participants, the investigators are able to research cardiovascular diseases, depression, fertility, arterial hypertension, and car accident injuries, among other areas.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22500
• Est. completion date: December 2075
• Est. primary completion date: December 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Spanish university graduates

Exclusion Criteria:

• not Spanish university graduates

Related Conditions & MeSH terms

• Chronic Disease
• Dietary Habits
• Lifestyle

Locations

Country	Name	City	State
Spain	University of Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Carlos S, De La Fuente-Arrillaga C, Bes-Rastrollo M, Razquin C, Rico-Campà A, Martínez-González MA, Ruiz-Canela M. Mediterranean Diet and Health Outcomes in the SUN Cohort. Nutrients. 2018 Mar 31;10(4). pii: E439. doi: 10.3390/nu10040439. — View Citation

Seguí-Gómez M, de la Fuente C, Vázquez Z, de Irala J, Martínez-González MA. Cohort profile: the 'Seguimiento Universidad de Navarra' (SUN) study. Int J Epidemiol. 2006 Dec;35(6):1417-22. Epub 2006 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		50 years
Secondary	Cardiovascular disease	cardiovascular death, acute coronary syndromes (myocardial infarction with or without ST elevation), revascularization procedures or fatal or non-fatal stroke.	50 years
Secondary	Obesity	BMI>30 kg/m2	50 years
Secondary	Depression	Diagnosed depression through the Structured Clinical Interview (SCID-I) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)	50 years
Secondary	Cognitive function	Telephone Interview of Cognitive Status-modified (TICS-m)	50 years

External Links

•   Web page of the SUN cohort