Did the PREDIMED trial test a mediterranean diet?

New England Journal of Medicine (Impact Factor: 55.87). 04/2013; 368(14):1353-4. DOI: 10.1056/NEJMe1301582
Source: PubMed
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    • "Finally, self-managing change includes making healthier food choices, and study designs include various approaches to supporting dietary change. In the PREDIMED trial, for example [15], food supplements of mixed nuts or olive oil were provided to assist with compliance with the Mediterranean diet, and this in itself was argued to influence the outcomes of the trial [16]. Based on previous experience with supplementing weight loss trials with walnuts [17] [18], we added a third arm to examine whether supplying a healthy food (walnuts) enhanced outcomes. "
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    ABSTRACT: Background: Integrating professional expertise in diet, exercise and behavioural support may provide more effective preventive health services but this needs testing. We describe the design and baseline results of a trial in the Illawarra region of New South Wales, Australia. Methods: The HealthTrack study is a 12month randomised controlled trial testing effects of a novel interdisciplinary lifestyle intervention versus usual care. The study recruited overweight and obese adults 25-54yrs. resident in the Illawarra. Primary outcomes were weight, and secondary outcomes were disease risk factors (lipids, glucose, blood pressure), and behaviour (diet, activity, and psychological factors). Protocols, recruitment and baseline characteristics are reported. Results: Between May 2014 and April 2015, 377 participants were recruited and randomised. The median age (IQR) of the mostly female sample (74%) was 45 (37-51) years. The sample comprised obese (BMI 32 (29-35) kg/m(2)) well educated (79% post school qualifications) non-smokers (96%). A high proportion reported suffering from anxiety (26.8%) and depression (33.7%). Metabolic syndrome was identified in 34.9% of the sample. Conclusions: The HealthTrack study sample was recruited to test the effectiveness of an interdisciplinary approach to preventive healthcare in self-identified overweight adults in the Illawarra region. The profile of participants gives some indication of those likely to use services similar to the trial design.
    Preview · Article · Oct 2015 · Contemporary clinical trials
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    • "The primary results were outstanding, showing a 30% reduction in cardiovascular events in the treatment arms, proving the effect of the diet [18]. There is some discussion as to whether the PREDIMED study tested the effects of the Mediterranean diet or the supplemental foods (olive oil and nuts) [19]. The recent analyses of the PREDIMED study [9,13] address this concern in part by confirming associations with key foods and food components, showing that it is all these influences occurring together. "
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    ABSTRACT: The recent publication of the PREDIMED trial provided definitive evidence that a Mediterranean diet provides protection against cardiovascular disease. Two articles published in BMC Medicine provide further understanding of why this may be the case, by considering contributory effects of olive oil, a core food in the diet, and polyphenols, a class of identifiable protective compounds. Using a number of statistical models, analyses were conducted to show around a 35% cardiovascular disease risk reduction in the highest consumers of olive oil and a similar degree of risk reduction for all-cause mortality comparing highest to lowest quintiles of polyphenol intake. The effects were an advance on cohort studies not related to trials. This suggests that it may be necessary to have better control of the background diet to enable exposure of the value of individual foods and nutrients in a dietary pattern, bearing in mind that, by nature, it is difficult to separate out effects of foods, nutrients and whole diets. Please see related articles: and
    Preview · Article · Jun 2014 · BMC Medicine

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