- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02669602
Dynamic Mediterranean Prospective Cohort: the SUN Project
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- University of Navarra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Spanish university graduates
Exclusion Criteria:
- not Spanish university graduates
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
No intervention
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality
Time Frame: 50 years
|
50 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular disease
Time Frame: 50 years
|
cardiovascular death, acute coronary syndromes (myocardial infarction with or without ST elevation), revascularization procedures or fatal or non-fatal stroke.
|
50 years
|
|
Obesity
Time Frame: 50 years
|
BMI>30 kg/m2
|
50 years
|
|
Depression
Time Frame: 50 years
|
Diagnosed depression through the Structured Clinical Interview (SCID-I) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
|
50 years
|
|
Cognitive function
Time Frame: 50 years
|
Telephone Interview of Cognitive Status-modified (TICS-m)
|
50 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Miguel A Martinez-Gonzalez, PhD, University of Navarra
Publications and helpful links
General Publications
- Carlos S, De La Fuente-Arrillaga C, Bes-Rastrollo M, Razquin C, Rico-Campa A, Martinez-Gonzalez MA, Ruiz-Canela M. Mediterranean Diet and Health Outcomes in the SUN Cohort. Nutrients. 2018 Mar 31;10(4):439. doi: 10.3390/nu10040439.
- Segui-Gomez M, de la Fuente C, Vazquez Z, de Irala J, Martinez-Gonzalez MA. Cohort profile: the 'Seguimiento Universidad de Navarra' (SUN) study. Int J Epidemiol. 2006 Dec;35(6):1417-22. doi: 10.1093/ije/dyl223. Epub 2006 Oct 22. No abstract available.
- Bazal P, Gea A, Navarro AM, Salas-Salvado J, Corella D, Alonso-Gomez A, Fito M, Munoz-Bravo C, Estruch R, Fiol M, Lapetra J, Serra-Majem L, Ros E, Rekondo J, Munoz MA, Basora J, Sorli JV, Toledo E, Martinez-Gonzalez MA, Ruiz-Canela M. Caffeinated coffee consumption and risk of atrial fibrillation in two Spanish cohorts. Eur J Prev Cardiol. 2021 May 22;28(6):648-657. doi: 10.1177/2047487320909065.
- Alonso-Pedrero L, Ojeda-Rodriguez A, Zalba G, Razquin C, Martinez-Gonzalez MA, Bes-Rastrollo M, Marti A. Association between ideal cardiovascular health and telomere length in participants older than 55 years old from the SUN cohort. Rev Esp Cardiol (Engl Ed). 2022 Apr;75(4):308-315. doi: 10.1016/j.rec.2021.04.002. Epub 2021 May 14. English, Spanish.
- Martin-Calvo N, Santiago Neri S, Segura G, Fernandez-Lazaro CI, Barberia-Latasa M, Martinez-Gonzalez MA. Pregestational BMI and higher offspring's risk of overweight/obesity in smoker and non-smoker mothers. Public Health Nutr. 2021 Sep;24(13):4204-4211. doi: 10.1017/S1368980020005194. Epub 2020 Dec 18.
- Hershey MS, Fernandez-Montero A, Sotos-Prieto M, Kales S, Gea A, Ruiz-Estigarribia L, Sanchez-Villegas A, Diaz-Gutierrez J, Martinez-Gonzalez MA, Ruiz-Canela M. The Association Between the Mediterranean Lifestyle Index and All-Cause Mortality in the Seguimiento Universidad de Navarra Cohort. Am J Prev Med. 2020 Dec;59(6):e239-e248. doi: 10.1016/j.amepre.2020.06.014. Epub 2020 Nov 18. Erratum In: Am J Prev Med. 2022 Jun;62(6):963.
- Alonso-Pedrero L, Ojeda-Rodriguez A, Martinez-Gonzalez MA, Zalba G, Bes-Rastrollo M, Marti A. Ultra-processed food consumption and the risk of short telomeres in an elderly population of the Seguimiento Universidad de Navarra (SUN) Project. Am J Clin Nutr. 2020 Jun 1;111(6):1259-1266. doi: 10.1093/ajcn/nqaa075.
- Gardeazabal I, Romanos-Nanclares A, Martinez-Gonzalez MA, Castello A, Sanchez-Bayona R, Perez-Gomez B, Razquin C, Aramendia-Beitia JM, Pollan M, Toledo E. Mediterranean dietary pattern is associated with lower incidence of premenopausal breast cancer in the Seguimiento Universidad de Navarra (SUN) Project. Public Health Nutr. 2020 Dec;23(17):3148-3159. doi: 10.1017/S1368980019003835. Epub 2020 Feb 24.
- Rico-Campa A, Martinez-Gonzalez MA, Alvarez-Alvarez I, Mendonca RD, de la Fuente-Arrillaga C, Gomez-Donoso C, Bes-Rastrollo M. Association between consumption of ultra-processed foods and all cause mortality: SUN prospective cohort study. BMJ. 2019 May 29;365:l1949. doi: 10.1136/bmj.l1949.
- Fresan U, Martinez-Gonzalez MA, Sabate J, Bes-Rastrollo M. Global sustainability (health, environment and monetary costs) of three dietary patterns: results from a Spanish cohort (the SUN project). BMJ Open. 2019 Feb 21;9(2):e021541. doi: 10.1136/bmjopen-2018-021541.
- Garcia-Arellano A, Martinez-Gonzalez MA, Ramallal R, Salas-Salvado J, Hebert JR, Corella D, Shivappa N, Forga L, Schroder H, Munoz-Bravo C, Estruch R, Fiol M, Lapetra J, Serra-Majem L, Ros E, Rekondo J, Toledo E, Razquin C, Ruiz-Canela M; SUN and PREDIMED Study Investigators. Dietary inflammatory index and all-cause mortality in large cohorts: The SUN and PREDIMED studies. Clin Nutr. 2019 Jun;38(3):1221-1231. doi: 10.1016/j.clnu.2018.05.003. Epub 2018 May 24.
- Mendonca RD, Carvalho NC, Martin-Moreno JM, Pimenta AM, Lopes ACS, Gea A, Martinez-Gonzalez MA, Bes-Rastrollo M. Total polyphenol intake, polyphenol subtypes and incidence of cardiovascular disease: The SUN cohort study. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):69-78. doi: 10.1016/j.numecd.2018.09.012. Epub 2018 Oct 4.
- Mendonca RD, Pimenta AM, Gea A, de la Fuente-Arrillaga C, Martinez-Gonzalez MA, Lopes AC, Bes-Rastrollo M. Ultraprocessed food consumption and risk of overweight and obesity: the University of Navarra Follow-Up (SUN) cohort study. Am J Clin Nutr. 2016 Nov;104(5):1433-1440. doi: 10.3945/ajcn.116.135004. Epub 2016 Oct 12.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Chronic Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
Radboud University Medical CenterRecruitingChronic Conditions, Multiple | Chronic ConditionNetherlands
-
Radboud University Medical CenterCompleted
-
Parker Research InstituteOak Foundation; Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre... and other collaboratorsRecruitingChronic Disease | Chronic Conditions, Multiple | Chronic ConditionDenmark
-
Parker Research InstituteOak Foundation; Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre... and other collaboratorsCompletedChronic Conditions, Multiple | Chronic ConditionDenmark
-
University of LeicesterUniversity Hospitals, Leicester; University of StrathclydeRecruitingChronic Obstructive Pulmonary Disease (COPD) | Chronic Obstructive Lung Disease | Chronic Obstructive Airway DiseaseUnited Kingdom
-
University of LimerickCompletedChronic Conditions, MultipleIreland
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan