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02 September 2010
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| [ Print-friendly version ] |
| Effects of Mediterranean diet on the primary prevention of cardiovascular disease |
| ISRCTN | ISRCTN35739639 |
| ClinicalTrials.gov identifier | |
| Public title | Effects of Mediterranean diet on the primary prevention of cardiovascular disease |
| Scientific title | Effects of a Mediterranean diet enriched with virgin olive oil or mixed nuts versus a low fat diet on the primary prevention of cardiovascular disease: a randomised controlled trial |
| Acronym | PREDIMED STUDY |
| Serial number at source | Red G03/140 |
| Study hypothesis |
A Mediterranean-style diet enriched with virgin olive oil or mixed nuts prevents cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke).
As of 05/05/2009 this record was updated to include an updated anticipated end date; the initial end date at the time of registration was 31/12/2010. At this time, the target number of participants was also updated; the initial target number of participants was n = 9000 high-risk participants. |
| Ethics approval | Added 07/05/2009: Approved by the Institutional Review Board of the Hospital Clinic at Barcelona, Spain, on 16th July 2002. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Cardiovascular disease |
| Participants - inclusion criteria |
Participants are community-dwelling high-risk persons with age 55 to 80 years for men and 60 to 80 years for women, without a history of cardiovascular disease (CHD), who fulfill at least one of the two following criteria:
1. Type two 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2003 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | n = 7500 high-risk participants |
| Interventions |
Participants are randomly assigned into three equal groups:
1. Mediterranean-style diet with added virgin olive oil 2. Mediterranean-style diet with added nuts 3. Low-fat diet according to American Heart Association guidelines Added 07/05/2009: All participants in the three arms will be treated and followed-up yearly from their inclusion to the second semester of 2011. |
| Primary outcome measure(s) |
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Added 07/05/2009: All participants are evaluated yearly for primary and secondary endpoints. |
| Secondary outcome measure(s) |
Death of any cause and incidence of angina leading to a revascularisation procedure, heart failure, diabetes mellitus, dementia, and cancer.
Other outcomes: 1. Changes in blood pressure 2. Body weight 3. Adiposity measures 4. Blood sugar 5. Lipid profile 6. Markers of inflammation 7. Other intermediate markers of cardiovascular risk Added 07/05/2009: All participants are evaluated yearly for primary and secondary endpoints. |
| Sources of funding |
1. Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (ref: G03/140)
2. Communal Patrimony Olivarero Foundation (Fundación Patrimonio Comunal Olivarero) (Spain) 3. Hojiblanca SA (Spain) 4. Borges SA (Spain) 5. Morella Nuts SA (Spain) 6. California Walnut Commission (USA) |
| Trial website | http://www.predimed.org |
| Publications |
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16818923
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17563030 3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19064829 |
| Contact name | Prof Ramon Estruch |
| Address |
Servicio de Medicina Interna
Hospital Clinic Villarroel, 170 |
| City/town | Barcelona |
| Zip/Postcode | 08036 |
| Country | Spain |
| Tel | +34 93 227 93 65 |
| Fax | +34 93 227 93 65 |
| restruch@clinic.ub.es | |
| Sponsor | Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) |
| Address | Sinesio Delgado, 6 |
| City/town | Madrid |
| Zip/Postcode | 28029 |
| Country | Spain |
| Tel | +34 91 822 21 00 |
| Fax | +34 91 387 77 89 |
| Oficina.informacion@isciii.es | |
| Sponsor website: | http://www.isciii.es |
| Date applied | 02/09/2005 |
| Last edited | 07/05/2009 |
| Date ISRCTN assigned | 05/10/2005 |
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