Considerations to facilitate a US study that replicates PREDIMED

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

Research output: Contribution to journalReview article

4 Citations (Scopus)

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 1 2018

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Mediterranean Diet
Diet
Cardiovascular Diseases
Nuts
Meals
Life Style
Clinical Trials
Food

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Jacobs, David R. ; Petersen, Kristina ; Svendsen, Karianne ; Ros, Emilio ; Sloan, Carol B. ; Steffen, Lyn M. ; Tapsell, Linda C. ; Kris-Etherton, Penny Margaret. / Considerations to facilitate a US study that replicates PREDIMED. In: Metabolism: Clinical and Experimental. 2018 ; Vol. 85. pp. 361-367.
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Considerations to facilitate a US study that replicates PREDIMED. / Jacobs, David R.; Petersen, Kristina; Svendsen, Karianne; Ros, Emilio; Sloan, Carol B.; Steffen, Lyn M.; Tapsell, Linda C.; Kris-Etherton, Penny Margaret.

In: Metabolism: Clinical and Experimental, Vol. 85, 01.08.2018, p. 361-367.

Research output: Contribution to journalReview article

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T1 - Considerations to facilitate a US study that replicates PREDIMED

AU - Jacobs, David R.

AU - Petersen, Kristina

AU - Svendsen, Karianne

AU - Ros, Emilio

AU - Sloan, Carol B.

AU - Steffen, Lyn M.

AU - Tapsell, Linda C.

AU - Kris-Etherton, Penny Margaret

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AB - 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.

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