Effects of Mediterranean diet on the primary prevention of cardiovascular disease

Not Applicable

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN35739639
• Lead Sponsor: Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)

Brief Summary

2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16818923 results 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17563030 results 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19064829 results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21508208 results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21708186 results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21802081 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22170359 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20875949 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22420890 sub-study results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22535754 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22541738 kidney function results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23034962 phylloquinone intake results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23130628 sub-study results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23432189 primary results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23637743 lifestyle and risk factor results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23526980 white blood cell results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23866098 mortality risk results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23760626 sTWEAK concentration results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23902780 transcriptomic results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24050803 blood pressure results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24229349 depression results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23149074 gazpacho consumption results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23332727 polyphenols results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24167545 iron-induced insulin resistance results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23942586 polymorphism results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24188615 heme iron intake results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23670794 cognition sub-study results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24259558 magnesium intake results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24393375 polymorphism results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24573661 prevention of diabetes results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24448738 carbohydrate response element binding protein results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24285581 carotid intima-media thickness results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24651160 plasma fatty acid composition results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24477299 beer consumption results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24574190 heart failure biomarkers results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24647393 vitamin K intake results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24886626 olive oil intake results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24886552 polyphenol intake results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24886552 re-analysis results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24552647 habitual polyphenol intake results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24925270 vascular wall inflammation and plaque vulnerability results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24787471 atrial fibrillation results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24871477 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25072784 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24990426 microRNA-410 regulated lipoprotein lipase variant rs13702 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25160563 blood pressure and depression results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25280390 results 2014 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/25316904 metabolic syndrome status 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25411285 fiber intake results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25315667 plasma nitric oxide and blood pressure results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25406242 telomere shortening results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25733627 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25961184 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26354530 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26290009 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26365989 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26561617 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30327364 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31003626 results (added 23/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30651193 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27903410 results (added 25/07/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29982310 results (added 05/08/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28392166 results (added 13/09/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29305130 results (added 27/09/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31722714 lysine pathway biomarker results (added 15/11/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31882021 longitudinal association results (added 31/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29352655 6 year follow up results (added 26/03/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32060497/ results (added 26/05/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31941372/ results (added 13/08/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33296468/ results (added 10/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33296471/ results (added 10/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34839386/ Sub-analysis in participants aged over 70 years (added 29/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35575609/ Arginine catabolism metabolites and atrial fibrillation or heart failure risk (added 18/05/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36739229/ Circulating citric acid cycle metabolites and risk of cardiovascular disease (added 06/02/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36958970/ AHA proposed 7 ideal cardiovascular health metrics and risk of atrial fibrillation (added 24/03/2023) 2023 Results article in https://doi.org/10.1007/s13105-023-00958-0 Plasma lipidome and risk of atrial fibrillation: results from the PREDIMED trial (added 03/04/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37716984/ (added 18/09/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37775736/ Association of diabetes with adherence to Mediterranean diet (added 02/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37949173/ Association between nuclear magnetic resonance spectroscopy markers and adherence to Mediterranean diet (added 13/11/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37948836/ Association between serum B12 levels and adherence to Mediterranean diet (added 13/11/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38093289/ Olive oil consumption and T2D and CVD risk (added 20/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-05
• Study Completion: 2011-12-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7447

Inclusion Criteria

Participants are community-dwelling high-risk persons aged 55 to 80 for men and aged 60 to 80 for women, without a history of cardiovascular disease (CHD), who fulfill at least one of the two following criteria:
1. Type 2 diabetes
2. Three or more of the risk factors:
2.1. Current smoker
2.2. Hypertension
2.3. Hypercholesterolemia (low density lipoprotein cholesterol [LDL-cholesterol] more than 160 mg/dl or treatment with hypolipidemic drugs)
2.4. High density lipoprotein cholesterol (HDL-cholesterol) less than 40 mg/dl
2.5. Overweight or obesity (body mass index more than 25 kg/m^2)
2.6. Family history of premature CHD

Exclusion Criteria

1. Previous history of cardiovascular disease
2. Any severe chronic illness
3. Immunodeficiency or human immunodeficiency virus (HIV) positive status
4. Illegal drug use or chronic alcoholism
5. History of allergy to olive oil or nuts
6. Low predicted likelihood of changing dietary habits according to the Prochaska and DiClemente stages of change model

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. <br><br>Added 07/05/2009:<br>All participants are evaluated yearly for primary and secondary endpoints.

Secondary Outcome Measures

Name	Time	Method
Death of any cause and incidence of angina leading to a revascularisation procedure, heart failure, diabetes mellitus, dementia, and cancer.<br><br>Other outcomes: <br>1. Changes in blood pressure<br>2. Body weight<br>3. Adiposity measures<br>4. Blood sugar<br>5. Lipid profile<br>6. Markers of inflammation<br>7. Other intermediate markers of cardiovascular risk<br><br>Added 07/05/2009:<br>All participants are evaluated yearly for primary and secondary endpoints.