Articles4 July 2006
A Randomized Trial
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    This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

    Background:

    The Mediterranean diet has been shown to have beneficial effects on cardiovascular risk factors.

    Objective:

    To compare the short-term effects of 2 Mediterranean diets versus those of a low-fat diet on intermediate markers of cardiovascular risk.

    Design:

    Substudy of a multicenter, randomized, primary prevention trial of cardiovascular disease (Prevención con Dieta Mediterránea [PREDIMED] Study).

    Setting:

    Primary care centers affiliated with 10 teaching hospitals.

    Participants:

    772 asymptomatic persons 55 to 80 years of age at high cardiovascular risk who were recruited from October 2003 to March 2004.

    Interventions:

    Participants were assigned to a low-fat diet (n = 257) or to 1 of 2 Mediterranean diets. Those allocated to Mediterranean diets received nutritional education and either free virgin olive oil, 1 liter per week (n = 257), or free nuts, 30 g/d (n = 258). The authors evaluated outcome changes at 3 months.

    Measurements:

    Body weight, blood pressure, lipid profile, glucose levels, and inflammatory molecules.

    Results:

    The completion rate was 99.6%. Compared with the low-fat diet, the 2 Mediterranean diets produced beneficial changes in most outcomes. Compared with the low-fat diet, the mean changes in the Mediterranean diet with olive oil group and the Mediterranean diet with nuts group were −0.39 mmol/L (95% CI, −0.70 to − 0.07 mmol/L) and − 0.30 mmol/L (CI, −0.58 to − 0.01 mmol/L), respectively, for plasma glucose levels; −5.9 mm Hg (CI, −8.7 to −3.1 mm Hg) and − 7.1 mm Hg (CI, −10.0 to −4.1 mm Hg), respectively, for systolic blood pressure; and −0.38 (CI, −0.55 to − 0.22) and − 0.26 (CI, −0.42 to −0.10), respectively, for the cholesterol–high-density lipoprotein cholesterol ratio. The Mediterranean diet with olive oil reduced C-reactive protein levels by 0.54 mg/L (CI, 1.04 to 0.03 mg/L) compared with the low-fat diet.

    Limitations:

    This short-term study did not focus on clinical outcomes. Nutritional education about low-fat diet was less intense than education about Mediterranean diets.

    Conclusion:

    Compared with a low-fat diet, Mediterranean diets supplemented with olive oil or nuts have beneficial effects on cardiovascular risk factors.

    *For a list of additional PREDIMED Study Investigators, see the Appendix.

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