Considerations to facilitate a US study that replicates PREDIMED

David R. Jacobs, Kristina S. Petersen, Karianne Svendsen, Emilio Ros, Carol B. Sloan, Lyn M. Steffen, Linda C. Tapsell, Penny M. Kris-Etherton

Research output: Contribution to journalReview article

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)361-367
Number of pages7
JournalMetabolism: clinical and experimental
Volume85
DOIs
StatePublished - Aug 2018

Keywords

  • Cardiovascular disease
  • Diet
  • Prevention
  • Randomized clinical trial
  • Study design

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    Jacobs, D. R., Petersen, K. S., Svendsen, K., Ros, E., Sloan, C. B., Steffen, L. M., Tapsell, L. C., & Kris-Etherton, P. M. (2018). Considerations to facilitate a US study that replicates PREDIMED. Metabolism: clinical and experimental, 85, 361-367. https://doi.org/10.1016/j.metabol.2018.05.001