Considerations to facilitate a US study that replicates PREDIMED.

Area of Science:

• Cardiovascular Disease Prevention
• Nutritional Epidemiology
• Dietary Interventions

Background:

• The PREDIMED trial demonstrated Mediterranean diet (MedDiet) efficacy in preventing cardiovascular disease (CVD) among high-risk individuals.
• Significant dietary and lifestyle differences exist between U.S. and Spanish populations, impacting MedDiet adherence.

Purpose of the Study:

• To assess the feasibility of replicating the PREDIMED trial's MedDiet intervention in the U.S. population.
• To propose dietary and behavioral recommendations for U.S. MedDiet replication.
• To hypothesize the impact of MedDiet adherence changes on CVD incidence.

Main Methods:

• Utilized the 14-point Mediterranean Diet Adherence Score (MEDAS) to quantify dietary patterns.
• Compared baseline MEDAS scores with those achieved during the PREDIMED intervention.
• Analyzed the contribution of free supplements (olive oil, nuts) to MEDAS changes.

Main Results:

• Baseline MEDAS in PREDIMED was approximately 8.5, increasing to nearly 11 in MedDiet groups versus 9 in controls.
• Supplements contributed minimally (0.5 points) to the observed MEDAS increase.
• Typical U.S. diets score 1-2 on the MEDAS, contrasting with PREDIMED's MedDiet groups.

Conclusions:

• Replication of the PREDIMED trial in the U.S. is scientifically feasible.
• A 2-point MEDAS increase is hypothesized to reduce CVD incidence, with a conservative target of a 4-point difference for U.S. replication.
• MedDiet adherence can be achieved through specific food choices and meal patterns, independent of supplements.