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LifestyleNCT02669602

Dynamic Mediterranean Prospective Cohort: the SUN Project

An observational study of Lifestyle and Chronic Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Lifestyle, Chronic Disease, Dietary Habits
How many people
22,500 participants
Where
1 siteSpain
Study dates
Dec 1999to Dec 2075
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Spanish university graduates

Who may be able to join

  • Spanish university graduates

Who cannot join

  • not Spanish university graduates

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

  • University of Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

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

Read the 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.

Keywords
Nutritional epidemiology, Prospective
Medical subject headings
Chronic Disease, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02669602
Study groupRoleWhat they receive
No interventionNo Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 50 years

Secondary outcomes (4)

  1. Cardiovascular disease

    cardiovascular death, acute coronary syndromes (myocardial infarction with or without ST elevation), revascularization procedures or fatal or non-fatal stroke.

    Measured: 50 years

  2. Obesity

    BMI>30 kg/m2

    Measured: 50 years

  3. Depression

    Diagnosed depression through the Structured Clinical Interview (SCID-I) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

    Measured: 50 years

  4. Cognitive function

    Telephone Interview of Cognitive Status-modified (TICS-m)

    Measured: 50 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startDec 1999
  3. Primary completionDec 2050 (estimated)
  4. Study completionDec 2075 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669602
Sponsor's protocol ID
SUN
Status last verified
May 2022
First submitted
11 Jan 2016
Last updated
31 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

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.

    PubMed 29614726

  • 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.

    PubMed 17060332

  • Menezes-Junior L, Martinez-Gonzalez MA, Martinez JA, de la Fuente-Arrillaga C, Moreno LA, Bes-Rastrollo M. Adherence to the 2025-2030 dietary guidelines (DGA) and risk of all-cause and cause-specific mortality: A prospective analysis in a middle-aged cohort. Clin Nutr. 2026 Sep 3;66:106779. doi: 10.1016/j.clnu.2026.106779. Online ahead of print.

    PubMed 42753340

  • Menezes-Junior L, Martinez-Gonzalez MA, Bullon-Vela V, Gonzalez-Cantero A, Martin-Gorgojo A, Bes-Rastrollo M. Long-term adherence to the Mediterranean Diet and risk of rheumatoid arthritis and psoriasis: 20-year follow-up of the SUN project. Am J Clin Nutr. 2026 Sep 4:101511. doi: 10.1016/j.ajcnut.2026.101511. Online ahead of print.

    PubMed 42697415

  • de la O V, Goni L, Zazpe I, Martinez-Gonzalez MA, Santiago S, Bes-Rastrollo M, Ruiz-Canela M. Long-term risk of overweight/obesity according to the protein quality index in a prospective middle-aged cohort. Clin Nutr. 2025 Sep;52:284-298. doi: 10.1016/j.clnu.2025.07.024. Epub 2025 Jul 30.

    PubMed 40816209

  • Gribble AK, Hershey MS, Lopez-Gil JF, Lan FY, Kales SN, Martinez-Gonzalez MA, Bes-Rastrollo M, Fernandez-Montero A. Role of the Intensity of Habitual Physical Activity in the Maintenance of Normal Blood Pressure: Findings From the SUN Longitudinal Cohort Study. J Am Heart Assoc. 2025 Jun 17;14(12):e038664. doi: 10.1161/JAHA.124.038664. Epub 2025 Jun 5.

    PubMed 40470663

  • Martinez-Gonzalez MA. Should we remove wine from the Mediterranean diet?: a narrative review. Am J Clin Nutr. 2024 Feb;119(2):262-270. doi: 10.1016/j.ajcnut.2023.12.020. Epub 2023 Dec 28.

    PubMed 38157987

  • Talavera-Rodriguez I, Fernandez-Lazaro CI, Hernandez-Ruiz A, Hershey MS, Galarregui C, Sotos-Prieto M, de la Fuente-Arrillaga C, Martinez-Gonzalez MA, Ruiz-Canela M. Association between an oxidative balance score and mortality: a prospective analysis in the SUN cohort. Eur J Nutr. 2023 Jun;62(4):1667-1680. doi: 10.1007/s00394-023-03099-8. Epub 2023 Feb 12.

    PubMed 36781422

  • 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.

    PubMed 34021573

  • 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.

    PubMed 33994338

  • 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.

    PubMed 33336642

  • 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.

    PubMed 33220762

  • 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.

    PubMed 32330232

  • 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.

    PubMed 32090723

  • 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.

    PubMed 31142450

Questions about this trial

What is this clinical trial studying?

An observational study of Lifestyle and Chronic Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 50 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669602, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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