Effect of an energy-restricted Mediterranean diet, physical activity and behavioral intervention on the primary prevention of cardiovascular disease
- Conditions
- Cardiovascular diseaseCirculatory System
- Registration Number
- ISRCTN89898870
- Lead Sponsor
- European Research Council (Belgium) / The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)
- Brief Summary
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30424822 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31005965 taste perception and genomics results (added 23/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31613346 results (added 16/10/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30287240 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31868210 results (added 24/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31870449 results (added 31/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30389673 results (added 22/01/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32063406 results (added 19/02/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32075623 results (added 24/02/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32103064 baseline cross-sectional analysis results (added 28/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33296471/ results (added 10/12/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33300039/ results (added 11/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33402165/ results (added 12/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33610419/ results (added 22/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33933749/ diet adherence and cardiometabolic risk factors results (added 05/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34020445/ gut microbiome analysis results (added 24/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34114008/ Data-Driven Clustering results (added 14/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34139471/ two-year follow up results (added 18/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34364236/ Validity of the energy-restricted Mediterranean Diet Adherence Screener (added 09/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34582548/ substudy results (added 29/09/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33556935/ (added 05/11/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34777250/ (added 16/11/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34846603/ longitudinal analysis (added 01/12/2021) Results article in https://pubmed.ncbi.nlm.nih.gov/35417452/ Association between cardiovascular risk factors and depression in participants with metabolic syndrome (added 14/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35846291/ Role of NAFLD on the Health Related QoL Response to Lifestyle in Patients With Metabolic Syndrome (added 19/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35941632/ Impulsivity is longitudinally associated with healthy and unhealthy dietary patterns in individuals with overweight or obesity and metabolic syndrome within the framework of the PREDIMED-Plus trial (added 09/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36084360/ Association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators (added 12/09/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36712515/ Impact of COVID-19 pandemic on the trial (added 31/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36870243/ Increase from low to moderate, but not high, caffeinated coffee consumption is associated with favorable changes in body fat (added 06/03/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36882739/ Prospective cohort analysis of water intake and hydration status (added 08/03/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37236477/ Environmental sustainability (added 30/05/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37443076/ Metabolic syndrome criteria and severity and carbon dioxide (CO2) emissions (added 17/07/2023) 2023 Results article in https://doi.org/10.1016/j.clnu.2023.06.030 Effect of a 3-year lifestyle intervention on telomere length in participants from PREDIMED-Plus: A randomized trial (added 24/07/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37559740/ Association of monetary diet cost of foods and diet quality in Spanish older adults (added 11/08/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37833678/ Association of adiposity with COVID-19 risk in older adults with overweight/obesity and metabolic syndrome (added 16/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37852024/ (added 19/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37851444/ (added 19/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38062915/ Mediterranean diet linked to microbial phenolic metabolites associated with better cognitive performance in an older population (added 18/12/2023) 2024 Results article in https://doi.org/10.1016/j.ajcnut.2024.02.021 Effect of 1-year lifestyle intervention with energy-reduced Mediterranean diet and physical activity promotion on the gut metabolome and microbiota: a randomized clinical trial (added 04/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38474858/ Beverage consumption and environmental sustainability (added 13/03/2024) 2024 Results article in https://doi.org/10.1161/jaha.123.031915 Associations of Alcohol Consumption With Left Atrial Morphology and Function in a Population at High Cardiovascular Risk (added 28/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38862960/ sex, APOE genotype, endocannabinoids and cognitive change (added 25/06/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39137622/ Long-term association between water intake and kidney function in a population at high cardiovascular risk (added 14/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 6874
1. Participants are community-dwelling high-risk people.
2. Men aged 55 to 75 years and women aged 60 to 75 years
3. Body mass index (BMI) between = 27 y < 40 kg/m2
4. No cardiovascular disease (CVD) at enrolment
5. Who fulfil at least 3 of the criteria for the metabolic syndrome (Alberti et al., 2009). Diabetic participants will represent not more than 25% of the final sample.
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 religi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 04/06/2018:<br>1. A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke<br>2. Changes in body weight<br>All participants are evaluated yearly for primary and secondary endpoints<br><br>Previous primary outcome measures:<br>1. A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke<br>2. Changes of body weight<br>3. Changes in quality of life<br>All participants are evaluated yearly for primary and secondary endpoints
- Secondary Outcome Measures
Name Time Method