Considerations to facilitate a US study that replicates PREDIMED

Metabolism. 2018 Aug:85:361-367. doi: 10.1016/j.metabol.2018.05.001. Epub 2018 May 5.

Abstract

The PREDIMED clinical trial provided strong evidence that a Mediterranean dietary pattern (MedDiet) could help prevent cardiovascular disease (CVD) events in high risk middle-aged/older people. This report considers the feasibility of replicating PREDIMED in the U.S., including recommendations for dietary and behavioral principles. A 14-point Mediterranean diet Adherence Score (MEDAS) guided the PREDIMED MedDiet recommendations. At baseline MEDAS points were ~8.5. During intervention this score increased to nearly 11 in MedDiet vs. 9 in control. In the MedDiet groups, only about 0.5 points of the net 2 point MEDAS increase was attributable to the gratis supplements of olive oil or nuts. An issue in a U.S. replication is the large difference in typical U.S. versus Spanish diet and lifestyle. A typical U.S. diet would achieve a MEDAS of 1-2. A replication is scientifically feasible with an assumption such as that the MedDiet reflects a continuum of specific food choices and meal patterns. As such, a 2 point change in MEDAS at any point on the continuum would be hypothesized to reduce incident CVD. A conservative approach would aim for a randomized 4 point MEDAS difference, e.g. 5-6 points vs. an average U.S. diet group that achieved only 1-2 points.

Keywords: Cardiovascular disease; Diet; Prevention; Randomized clinical trial; Study design.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.
  • Review

MeSH terms

  • Cardiovascular Diseases / prevention & control*
  • Diet, Mediterranean*
  • Humans
  • Randomized Controlled Trials as Topic
  • Research Design*