Format

Send to

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

Considerations to facilitate a US study that replicates PREDIMED.

Author information

1
Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States. Electronic address: jacob004@umn.edu.
2
Department of Nutritional Sciences, Pennsylvania State University, College Park, PA, United States.
3
Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway.
4
Lipid Clinic, Endocrinology & Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer, Hospital Clínic, Barcelona, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Spain.
5
California Walnut Board and Commission, 101 Parkshore Drive, Suite 250, Folsom, CA 95630, United States.
6
Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.
7
School of Medicine and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.

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

PMID:
29733820
DOI:
10.1016/j.metabol.2018.05.001
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center