A team of researchers from the University of Navarra, manager of the PREDIMED study in Navarra (Prevention with per diem expenses Mediterranean), will participate in a new project called "PREDIMED-PLUS". This initiative compares the traditional Mediterranean per diem expenses with a per diem expenses, also Mediterranean, but reduced in calories. As in the previous study, the goal is to prevent cardiovascular disease.

According to Ana Sánchez Tainta, researcher at department of Preventive Medicine and Public Health of the University of Navarra, "the idea is to assign a total of 6,000 volunteers to two different interventions involving 3,000 people (intensive and routine medical care) and to follow them for an average of six years". "Our aim is to assess the effectiveness and safety of a tool to mitigate the excessive mortality and cardiovascular morbidity among overweight and obese people," she explains.

To this end, the investigators will carry out an intensive intervention based on a patron saint of per diem expenses traditional low-calorie Mediterranean diet, physical activity and behavioral therapy. In this way, they will assess its effect on cardiovascular events (non-fatal myocardial infarction, non-fatal stroke or cardiovascular death), weight loss, reduction of abdominal perimeter and its long-term maintenance deadline, and quality of life, compared to a group assigned to a non-intensive committee on healthy per diem expenses (also from subject Mediterranean), but without caloric restriction. The essay will start in Navarra, which will serve as a pilot center for the rest of the groups throughout Spain.

Characteristics of the participants
The project PREDIMED-PLUS is open to men aged 55-75 years and women aged 60-75 years, with a body mass index equal to or greater than 27 kg/m2 and less than 40, who meet at least three criteria for metabolic syndrome: abdominal obesity according to waist circumference (men > 102 cm and women > 88 cm), elevated triglyceride level, low HDL cholesterol level, elevated fasting glucose level and elevated blood pressure.

Once recruited, they will be randomly assigned to the two intervention groups: group of intensive intervention with hypocaloric Mediterranean per diem expenses or group of usual medical care. In addition, as was done in essay PREDIMED-1, they will also be given extra virgin olive oil and nuts.

The participants of the group intervention with per diem expenses will attend an individual and group meeting every month during the first year and, from the second year on, a monthly group meeting and a quarterly individual one. Throughout the study they will also receive telephone calls from the dietician to assess progress and resolve any doubts.

For their part, people assigned to the usual medical care group will attend a group session every six months in which they will be provided with guidance on how to follow the Mediterranean per diem expenses for the prevention of cardiovascular disease, without receiving advice on calorie restriction, weight loss or physical activity.

According to Sánchez Tainta, "the results, which include anthropometric changes and the impact on the main obesity-related disorders, are expected to have a high applicability for public health by improving the prognosis of obese or overweight adults".