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18 November 2008
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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 | |
| 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). |
| Ethics approval | Not provided at time of registration |
| 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 | 31/12/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | n = 9000 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 |
| Primary outcome measure(s) | A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. |
| 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 |
| 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 |
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/16818923 2. http://www.ncbi.nlm.nih.gov/pubmed/17563030 |
| 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 2279365 |
| Fax | +34 93 2279365 |
| 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 918222100 |
| Fax | +34 913877789 |
| Oficina.informacion@isciii.es | |
| Sponsor website: | http://www.isciii.es |
| Date applied | 02/09/2005 |
| Last edited | 19/02/2008 |
| Date ISRCTN assigned | 05/10/2005 |
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