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Effect of an energy-restricted Mediterranean diet, physical activity and behavioral intervention on the primary prevention of cardiovascular disease

Cardiovascular effect of an intensive weight-loss lifestyle intervention based on an energy-restricted traditional Mediterranean diet (Mediet) together promotion of physical activity and behavioral support in comparison with a less intensive program using Mediet, but without energy restriction or other lifestyle changes: a randomized field trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89898870
Enrollment
6000
Registered
2014-07-24
Start date
2013-09-05
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Cardiovascular disease Circulatory System

Interventions

Participants are randomly assigned into two equal groups: 1. Low-intensity intervention with a 14-item Mediet (with supplemental extra-virgin olive oil and tree nuts given at no cost for the particip

Sponsors

European Research Council (Belgium) / The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Community-dwelling high-risk people 2. Men aged 55 to 75 years and women aged 60 to 75 years 3. Body mass index (BMI) =27 and <40 kg/m2 4. No cardiovascular disease (CVD) at enrolment 5. Who fulfil at least three of the criteria for the metabolic syndrome (Alberti et al., 2009). Diabetic participants will represent not more than 25% of the final sample.

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 04/06/2018: 1. Illiteracy or inability/unwillingness to give written informed consent or communicate with study staff 2. Institutionalization (the participant is a permanent or long-stay resident in a nursing home) 3. Documented history of previous CVD, including angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or haemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (new york heart association class II or IV); hypertrophic cardiomyopathy; or history of aortic aneurysm 4. Active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer) 5. Impossibility to follow the recommended diet (for religious reasons, swallowing disorders, or other reasons) or to perform physical activity 6. A low predicted likelihood to change dietary habits according to the Prochaska and Diclemente stages of change model (Nigg et al., 1999) 7. Inability to follow the scheduled intervention visits (institutionalized individuals, lack of autonomy, unable to walk, lack of a stable address, travel plans, or other reason that render the subject unable to attend scheduled visits) 8. Body weight loss >5 kg during the 6 months prior to the screening visit 9. Intention to undergo bariatric surgery in the next 6 months 10. History of very low-caloric diet during the 6 months prior to the screening visit 11. Prior bariatric surgery or indication and willingness to receive a surgical procedure for weight loss in the near future 12. History of inflammatory bowel disease or small bowel resection 13. Obesity of known endocrine origin (with the exception of treated hypothyroidism) 14. Food allergy to any Mediet component 15. Immunodeficiency or HIV-positive status 16. Liver cirrhosis or chronic renal failure 17. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression with hospitalization in past 6 months 18. Any severe co-morbid condition with less than 24-month life expectancy 19. Alcohol abuse or addition (total daily alcohol intake >50 g) or drug abuse within the past 6 months 20. History of major organ transplantation 21. Concurrent therapy with immunosuppressive drugs or cytotoxic agents 22. Current treatment with systemic corticosteroids 23. Current use of weight loss medication 24. Concurrent participation in another randomised clinical trial 25. Patients with an acute infection or inflammation (i.e., pneumonia) are allowed to participate in the study 3 months after resolution of their condition 26. Any other condition that may interfere with the completion of the study protocol Previous exclusion criteria: 1. Unable or unwilling to give written informed consent or communicate with study staff 2. Documented history of previous CVD, including angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or haemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (new york heart association class II or IV); hypertrophic cardiomyopathy; or history of aortic aneurysm 3. Active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer) 4. Impossibility to follow the recommended diet (for religio

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 04/06/2018: 1. A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 2. Changes in body weight All participants are evaluated yearly for primary and secondary endpoints Previous primary outcome measures: 1. A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 2. Changes of body weight 3. Changes in quality of life All participants are evaluated yearly for primary and secondary endpoints—

Secondary

MeasureTime frame
Current secondary outcome measures as of 15/07/2019: Death of any cause, changes in waist circumference, and incidence of acute coronary syndrome (unstable angina), coronary revascularization (percutaneous or surgical), atrial fibrillation, peripheral artery disease, heart failure, venous thrombosis, type 2 diabetes mellitus and its complications, dementia, Parkinson disease, major unipolar depression, osteoporotic fractures, cholelithiasis or cholecystectomy, symptomatic gout, transient ischemic attack, cataract, venous thromboembolism or cancer (breast, prostate, lung, colorectal, or stomach) and serum metabolome changes. Other intermediate outcomes are changes in: 1. Blood pressure 2. Fasting blood sugar 3. Serum lipid profile 4. Markers of inflammation 5. Other intermediate markers of cardiovascular risk 6. Overall diet and nutrient intake 7. Medication use 8. ECGs 9. Cognitive function, quality of life, and psychological and neuropsychological scores 10. Microbiome 11. Epigenetic tags (methylation, miRNA, lncRNA) 12. Genetic polymorphisms 13. Gene expression 13. Taste and odor perception tests All participants are evaluated yearly for primary and secondary endpoints Previous secondary outcome measures as of 06/02/2019: Death of any cause, changes in waist circumference, and incidence of acute coronary syndrome (unstable angina), coronary revascularization (percutaneous or surgical), atrial fibrillation, peripheral artery disease, heart failure, venous thrombosis, type 2 diabetes mellitus and its complications, dementia, Parkinson disease, major unipolar depression, osteoporotic fractures, cholelithiasis or cholecystectomy, symptomatic gout, transient ischemic attack, cataract, venous thromboembolism or cancer (breast, prostate, lung, colorectal, or stomach). Other intermediate outcomes are changes in: 1. Blood pressure 2. Fasting blood sugar 3. Serum lipid profile 4. Markers of inflammation 5. Other intermediate markers of cardiovascular risk —

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 5, 2026