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Effects of Mediterranean diet on the primary prevention of cardiovascular disease

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35739639
Enrollment
7500
Registered
2005-10-05
Start date
2003-10-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Circulatory System Cardiovascular disease

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 He

Sponsors

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 4, 2026