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Feb 25, 2013 ( Epub ahead of print

Feb 25, 2013 ( Epub ahead of print. Initial research team G 03/140 RD 06/0045 CIBERobn. www.predimed.es. Food industry : only food items. 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. Random.

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Feb 25, 2013 ( Epub ahead of print

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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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