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A Randomized Controlled Trial

Montserrat Fitó, MD, PhD; Mònica Guxens, MD; Dolores Corella, DPharm, PhD; Guillermo Sáez, MD, PhD; Ramón Estruch, MD, PhD; Rafael de la Torre, DPharm, PhD; Francesc Francés, MD; Carmen Cabezas, MD; María del Carmen López-Sabater, DPharm, PhD; Jaume Marrugat, MD, PhD; Ana García-Arellano, PhD; Fernando Arós, MD, PhD; Valentina Ruiz-Gutierrez, PhD; Emilio Ros, MD, PhD; Jordi Salas-Salvadó, MD, PhD; Miquel Fiol, MD, PhD; Rosa Solá, MD, PhD; María-Isabel Covas, DPharm, PhD; for the PREDIMED Study Investigators

Arch Intern Med. 2007;167(11):1195-1203.

Background  Despite the richness in antioxidants of the Mediterranean diet, to our knowledge, no randomized controlled trials have assessed its effect on in vivo lipoprotein oxidation.

Methods  A total of 372 subjects at high cardiovascular risk (210 women and 162 men; age range, 55-80 years), who were recruited into a large, multicenter, randomized, controlled, parallel-group clinical trial (the Prevención con Dieta Mediterránea [PREDIMED] Study) directed at testing the efficacy of the traditional Mediterranean diet (TMD) on the primary prevention of coronary heart disease, were assigned to a low-fat diet (n = 121) or one of 2 TMDs (TMD + virgin olive oil or TMD + nuts). The TMD participants received nutritional education and either free virgin olive oil for all the family (1 L/wk) or free nuts (30 g/d). Diets were ad libitum. Changes in oxidative stress markers were evaluated at 3 months.

Results  After the 3-month interventions, mean (95% confidence intervals) oxidized low-density lipoprotein (LDL) levels decreased in the TMD + virgin olive oil (–10.6 U/L [–14.2 to –6.1]) and TMD + nuts (–7.3 U/L [–11.2 to –3.3]) groups, without changes in the low-fat diet group (–2.9 U/L [–7.3 to 1.5]). Change in oxidized LDL levels in the TMD + virgin olive oil group reached significance vs that of the low-fat group (P = .02). Malondialdehyde changes in mononuclear cells paralleled those of oxidized LDL. No changes in serum glutathione peroxidase activity were observed.

Conclusions  Individuals at high cardiovascular risk who improved their diet toward a TMD pattern showed significant reductions in cellular lipid levels and LDL oxidation. Results provide further evidence to recommend the TMD as a useful tool against risk factors for CHD.

Trial Registration  isrctn.org Identifier: ISRCTN35739639

Author Affiliations: Lipids and Cardiovascular Epidemiology Unit (Drs Fitó, Marrugat, and Covas) and the Pharmacology Research Unit (Dr de la Torre), Institut Municipal d’Investigació Mèdica (IMIM–Hospital del Mar), Barcelona, Spain; Universitat Autònoma de Barcelona, Barcelona (Dr Guxens); Departments of Preventive Medicine and Public Health (Drs Corella and Francés) and Biochemistry and Molecular Biology (Dr Saez), School of Medicine, University of Valencia, Valencia, Spain; Department of Internal Medicine (Dr Estruch) and Endocrinology and Nutrition Service (Dr Ros), Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi Sunyer, Barcelona; Catalan Institute for Health, Barcelona (Dr Cabezas); Department of Nutrition and Bromatology, University of Barcelona, Barcelona (Dr López-Sabater); Department of Preventive Medicine and Public Health, University of Navarra (Dr García-Arellano); Department of Cardiology, Hospital Txagorritxu, Vitoria, Spain (Dr Arós); Instituto de la Grasa, Consejo Superior de Investigaciones Científicas, Sevilla, Spain (Dr Ruiz-Gutierrez); Human Nutrition Department, School of Medicine, University Rovira i Virgili, Reus, Spain (Drs Salas-Salvadó and Solá); University Institute for Health Sciences Investigation, Palma de Mallorca, Spain (Dr Fiol); and CIBER Fisiopatología de la Obesidad y Nutrición (Drs Fitó, Corella, Estruch, de la Torre, Ros, and Covas) and CIBER of Epidemiología Epidemiología (Dr López-Sabater), Instituto Salud Carlos III, Madrid, Spain.

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