
The PREDIMED trial is a Spanish multicentre randomised controlled trial (RCT) that assessed the long-term effects of the Mediterranean diet on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular (CV) risk. The trial was designed to determine the potential of the Mediterranean diet in the primary prevention of CVD, without imposing any energy restriction. The PREDIMED trial is a significant milestone in nutrition intervention research, indicating the benefits of the traditional Mediterranean diet in preventing CVD in high-risk individuals.
| Characteristics | Values |
|---|---|
| Purpose | To assess the long-term effects of the Mediterranean diet on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular risk |
| Study Design | Spanish multicenter randomized controlled trial (RCT) |
| Dietary Intervention | Mediterranean Diet (MD) with extra virgin olive oil (EVOO) or nuts, without energy restriction |
| Control Group | Low-fat control diet |
| Number of Participants | 7,447 individuals with a high risk of heart disease |
| Duration | 4.8 years |
| Outcomes Assessed | Risk of heart attack, stroke, and death from cardiovascular causes; incidence of breast cancer; risk of developing type 2 diabetes |
| Results | 31% lower risk of combined heart attack, stroke, and CV death in the MD + EVOO group; 28% lower risk in the MD + Nuts group; 52% reduction in the risk of developing type 2 diabetes with MD compared to the control group |
| Limitations | Early termination after 4.8 years; issues with randomization and allocation concealment |
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What You'll Learn
- The PREDIMED trial is a milestone in nutrition intervention that indicated the benefits of the traditional Mediterranean diet
- The trial studied the effects of a Mediterranean diet on cardiovascular disease prevention
- The Mediterranean diet may reduce the risk of type 2 diabetes
- Nuts and olive oil are important sources of fat and antioxidants
- The trial assessed the long-term effects of the Mediterranean diet

The PREDIMED trial is a milestone in nutrition intervention that indicated the benefits of the traditional Mediterranean diet
The trial included 7,447 individuals with a high risk of heart disease who followed either a Mediterranean diet with added extra virgin olive oil, a Mediterranean diet with added nuts, or a low-fat control group. The study lasted for 4.8 years and focused on the diet's potential effect on heart attack, stroke, and death from cardiovascular causes. The results showed that the Mediterranean diet groups had a statistically significant reduction in the rate of the composite primary outcome of myocardial infarction (MI), cerebrovascular accident (CVA), or cardiovascular (CV) death.
The PREDIMED trial also assessed the incidence of breast cancer and found that the Mediterranean diet may reduce the risk of developing type 2 diabetes by 52%risk-reducing effects of the Mediterranean diet on major health problems and risk factors. For example, those who consumed nuts as part of a Mediterranean diet had a 16-63% lower risk of death during the study period.
In conclusion, the PREDIMED trial is a landmark study that provides powerful evidence of the benefits of the traditional Mediterranean diet in the primary prevention of CVD and other health outcomes. It has contributed significantly to the available literature on the potential health benefits of the Mediterranean diet.
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The trial studied the effects of a Mediterranean diet on cardiovascular disease prevention
The PREDIMED trial, or PREvención con DIeta MEDiterránea, is a Spanish multicentre randomised controlled trial (RCT) that studied the effects of a Mediterranean diet on cardiovascular disease prevention. The trial assessed the long-term effects of the Mediterranean diet, without any energy restriction, on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular risk.
The Mediterranean diet is a nutritional pattern shared by people living in the olive-tree-growing areas of the Mediterranean basin. It is typically rich in vegetables, fruits, beans, nuts, seeds, breads, unrefined grains, and olive oil, with moderate inclusion of fish and wine, and minimal intake of meats and full-fat dairy products.
The PREDIMED trial involved 7,447 individuals with a high risk of heart disease who followed either a Mediterranean diet with added extra virgin olive oil, a Mediterranean diet with added nuts, or a low-fat control diet. The study lasted for 4.8 years and focused on the diet's potential effect on heart attack, stroke, and death from cardiovascular causes.
The results of the trial showed that the Mediterranean diet groups had a statistically significant reduction in the rate of the composite primary outcome of myocardial infarction (MI), cerebrovascular accident (CVA), or cardiovascular death. The risk of combined heart attack, stroke, and death from heart disease was lower by 31% in the Med + Olive Oil group and 28% in the Med + Nuts group. Additionally, the PREDIMED trial also found that the Mediterranean diet appeared to reduce the risk of developing type 2 diabetes by 52% compared to a low-fat control group.
In conclusion, the PREDIMED trial provided evidence that the Mediterranean diet may be effective in the primary prevention of cardiovascular disease and type 2 diabetes, especially in individuals at high risk.
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The Mediterranean diet may reduce the risk of type 2 diabetes
The PREDIMED trial is a Spanish multicentre randomised controlled trial (RCT) that assessed the long-term effects of the Mediterranean diet (MD) on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular (CV) risk. The trial found that the Mediterranean diet may help reduce the risk of developing type 2 diabetes.
The Mediterranean diet is a nutritional pattern shared by people living in the olive-tree-growing areas of the Mediterranean basin. It is typically rich in vegetables, fruits, beans, nuts, seeds, breads, unrefined grains, and olive oil, with moderate inclusions of fish and wine, and minimal intake of meat and full-fat dairy products.
The PREDIMED trial studied 418 people without diabetes who followed either a Mediterranean diet or a low-fat control diet for 4 years. In the two Mediterranean diet groups, 10% and 11% of people developed diabetes, compared to 17.9% in the low-fat control group. This indicated that the Mediterranean diet may reduce the risk of developing type 2 diabetes by up to 52%.
The trial also found that consuming nuts as part of a Mediterranean diet may significantly reduce the risk of death. After 5 years, those who consumed nuts had a 16-63% lower risk of death during the study period.
In addition to its potential benefits for diabetes and mortality risk, the PREDIMED trial also demonstrated the Mediterranean diet's positive impact on cardiovascular health. The trial showed a 31% lower risk of combined heart attack, stroke, and death from heart disease in the Mediterranean diet group with added olive oil, and a 28% lower risk in the group with added nuts.
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Nuts and olive oil are important sources of fat and antioxidants
The PREDIMED trial is a Spanish multicentre randomised controlled trial (RCT) that was designed to assess the long-term effects of the Mediterranean diet on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular (CV) risk. The trial is a milestone of nutrition intervention that indicated with powerful evidence the benefits of the traditional Mediterranean diet in the primary prevention of CVD in individuals at high risk.
Nuts and olive oil are important components of the Mediterranean diet, which is rich in total and monounsaturated fats. Nuts and olive oil are also sources of antioxidants, which can help to prevent oxidation and reduce the risk of CVD. The PREDIMED trial found that a Mediterranean diet supplemented with extra virgin olive oil or nuts reduced the risk of combined heart attack, stroke, and death from heart disease by 31% and 28%, respectively, compared to a low-fat control group.
The Mediterranean diet is not a single dietary pattern, but it does have common features, including an emphasis on vegetables, fruits, beans, nuts, seeds, breads, unrefined grains, and olive oil; the inclusion of fish and wine; and minimal intake of meats and full-fat dairy products. Such a diet has been shown to be associated with a substantially reduced risk of cardiovascular disease.
In addition to reducing the risk of CVD, the Mediterranean diet has also been found to reduce the risk of developing type 2 diabetes. A 2011 study as part of the PREDIMED-Reus nutrition intervention randomized trial found that after four years, 10% and 11% of participants in the two Mediterranean diet groups had developed diabetes, compared to 17.9% in the low-fat control group. This indicates a 52% reduction in the risk of developing type 2 diabetes.
Furthermore, the PREDIMED trial has also assessed the incidence of breast cancer. While the evidence on the role of the Mediterranean diet in the onset of breast cancer is still limited, the findings of the PREDIMED study are in agreement with the available literature and are statistically strengthened by its prospective, randomized, and controlled design.
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The trial assessed the long-term effects of the Mediterranean diet
The PREDIMED trial was a Spanish multicentre randomised controlled trial (RCT) designed to assess the long-term effects of the Mediterranean diet on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular risk. The Mediterranean diet (MD) is the nutritional pattern shared by people living in the olive-tree-growing areas of the Mediterranean basin. It is known for its potential to prevent cardiovascular diseases (CVDs).
The PREDIMED study was a dietary intervention study that analysed the risk-reducing effects of the MD on major health problems and risk factors. The trial focused on the diet's potential effect on heart attack, stroke, and death from cardiovascular causes. The results showed that the Mediterranean diet groups reached a statistically significant reduction in the rate of the composite primary outcome of MI, CVA, or CV death. The risk of combined heart attack, stroke, and death from heart disease was lower by 31% in the Med + Olive Oil group and 28% in the Med + Nuts group.
The PREDIMED trial also assessed the Mediterranean diet's impact on the onset of breast cancer. The findings of the trial indicated that the MD could play a role in primary prevention of CVD in individuals at high risk. Additionally, the trial found that the Mediterranean diet appeared to reduce the risk of developing type 2 diabetes by 52% when compared to a low-fat control group.
The PREDIMED trial is a significant milestone in nutrition intervention research, providing powerful evidence of the benefits of the traditional Mediterranean diet. The trial's results demonstrate the comprehensive nature of the Mediterranean diet, which focuses on a variety of foods and nutrients rather than a single approach.
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Frequently asked questions
The PREDIMED (PREvención con DIeta MEDiterránea) trial was designed to assess the long-term effects of the Mediterranean diet, without any energy restriction, on the incidence of cardiovascular disease (CVD) in individuals at high cardiovascular (CV) risk.
The PREDIMED trial found that the Mediterranean diet appeared to improve various risk factors for heart disease. The trial also found that the Mediterranean diet may significantly reduce the risk of death, especially when nuts were included in the diet. The trial also found that the Mediterranean diet may reduce the risk of developing type 2 diabetes by 52%.
There were some limitations to the PREDIMED trial. Firstly, there were issues with the randomization scheme, as some participants sharing households were assigned to the same group, and one centre randomized entire clinics rather than individual patients. Secondly, the trial was terminated early after a median follow-up of 4.8 years, which may have impacted the results.

























