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 articlepeer-review

8 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

Bibliographical note

Funding Information:
This work was supported by the California Walnut Commission .

Funding Information:
Carol Sloan is a full time consultant of the Commission. All other authors received compensation from the Commission while participating in this Working Group. DRJ, LMS, and PMK-E have grants from NIH. KS has a grant from Mills DA (Norway). ER has received grants from CWC. LMS has grants from CWC and Dairy Management. PMK-E has grants from CWC; McCormick Science Institute; NCBA; Dried Fruit and Nut Council; CA Strawberry Commission; Ocean Spray Cranberries; and Canola Oil Council of Canada. DRJ, ER, LMS, LCT and PMK-E are non-paid members of the CWC Scientific Advisory Committee. LCT is a member of the Science Advisory Council of the McCormick's Science Institute.

Keywords

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

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