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PREDIMED Trial: Mediterranean Diet Intervention & Cardiovascular Health

Initial research on PREDIMED trial focusing on Mediterranean diet's impact on cardiovascular health through dietary interventions involving olive oil, nuts, and other food items. Primary and secondary outcomes evaluated.

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PREDIMED Trial: Mediterranean Diet Intervention & Cardiovascular Health

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  1. Feb 25, 2013 (Epubahead of print

  2. Initialresearchteam G 03/140 RD 06/0045 CIBERobn www.predimed.es

  3. Foodindustry: onlyfooditems Provision of Olive oil ~2 000 l/wk Provision of nuts 30 kg/wk walnuts 15 kg/wk almonds ~125,000 $/yr ~350,000 $/yr

  4. Random PREDIMED TRIAL: DESIGN • Smoking • Hypertension •  LDL •  HDL • Overweight/obes • Familyhistory • Men: 55-80 yr • Women: 60-80 yr • High CV risk without CVD type 2 diabetics 3+ risk factors All free of CVD at baseline

  5. Recruitment: primary care N= 7,447

  6. Random www.predimed.es

  7. Primary end-point: either • cardiovascular death • myocardial infarction • stroke www.predimed.es

  8. Virgin olive oil PREDIMED: intervention Introduce changes in theoverallfoodpattern • Mediterraneandiet: 2 groups • Total Fat: ad libitum • High in • MUFA (virgin olive oil) • Fish • Fruits, vegetables, legumes • Low in meats & dairy • alcohol permitted: wine • Low-fatdiet - Control • Reduce everyfat • Increase CHO • No Energyrestriction • No specificrecommendationonPhysicalActivity tocopherols polyphenols flavonoids phytosterols www.predimed.es

  9. What is the Mediterranean diet?

  10. Olive oilmainculinaryfat • Olive oil >=4tablespoons/d • Vegetables>=2 serv./d • Fruits>=3 serv./d • Red meats<1/d • Butter, marg, cream<1/d • Soda drinks<1/d 8. Wine >=7 glasses/wk 9. Legumes >=3/wk 10. Fish & seafood >=3/wk 11. Cakes, sweets <3/wk 12. Nuts >=3/wk 13. Poultry> red meats 14. Sofrito >=2/wk 14-item screener

  11. Martínez-Gonzalez et al. IntJ Epidemiol2012;41:377 3 Sofrito

  12. August 2012 Volume 7 Isue8 e43134

  13. Strategiesforbehaviorchange Repeated personal contacts: every3-mo Groupsessions: every3-mo Holisticapproach • Writteninformation • Self-monitoring • Individualizedgoal-setting • Quick feedback • Individual motivational interviews (every3-mo) • adapted to the patient’s features • clinical condition • preferences • beliefs • expressed in servings/d toimproveunderstanding

  14. 1 l/week 30 g/day Additionalstrategies • Seasonalbuyinglists • Menus and recipes Only in the 2 MeDietgroups • Provision of keyfooditemsfor free Negotiatedgoalsetting • Contractedagreement • Understandable: units=servings Optionsforthenegotiation • Servingsize • Frequency of consumption • Way of cooking

  15. 3-yr attainments (%) for each of the 14 items MeDiet + Virgin olive oil MeDiet + mixed nuts Control group

  16. FFQ: Changes in Energy, Nutrient and Supplemental Food Intake by Study Arm MeDiet + Virgin olive oil MeDiet + mixed nuts Control group p<.001 except fiber (p=0.10) & SFA (p=0.004) p<.001 except SFA (p=0.30) Energy x 1000 Kcal Prot (%E) CHO (%E) Fiber (g/d) Fat (%E) SFA (%E) MUFA (%E) PUFA (%E) Nuts (%E) Olive O. (%E)

  17. Urinary hydroxytyrosol concentrations (95% confidence intervals) at baseline and at 1, 3 and 5 years of follow-up (N = 750).

  18. Plasma alpha-linolenic acid (%) in the three arms of the trial (95% confidence intervals) at baseline and at 1, 3 and 5 years of follow-up (N = 375).

  19. N Engl J Med 2013 Suppl. Appendix

  20. Primaryend-point (MI, strokeordeathfrom CV causes) Cruderates / 1000 person-years N Engl J Med 2013 www.predimed.es

  21. Primaryend-point N Engl J Med 2013 (1). Stratifiedaccordingtorecruiting center and adjustedfor sex, age, familyhistory of prematurecoronaryheartdisease, and smoking status. (2) Additionalllyadjustedforbody-massindex, waist-to-heightratio,hypertensionat baseline, dyslipidemia at baseline, and diabetes at baseline.

  22. Primaryend-point (MI, strokeordeathfrom CV causes)

  23. Secondaryend-points N Engl J Med 2013 Stratifiedaccordingtorecruiting center and adjustedfor sex, age, familyhistory of prematurecoronaryheartdisease, and smoking status,body-massindex, waist-to-heightratio,hypertensionat baseline, dyslipidemia at baseline, and diabetes at baseline.

  24. Total mortality

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