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The PREDIMED trial

The PREDIMED trial. JAMA 2008;299:2437. PREDIMED TRIAL. Rationale Funding sources Methods and intervention protocol Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) Cross-sectional assessments: Diet & inflammatory markers (Eur J Clin Nutr 2007)

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The PREDIMED trial

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  1. The PREDIMED trial

  2. JAMA 2008;299:2437

  3. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  4. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  5. Evolution of designs High High Randomized Trial Cohort Nested case - control Quality of evidence Quality of evidence Case - control Ecological ( cross - cultural, international comparisons ) Low Low

  6. Mediterranean Food pattern • Rapidly increasing evidence • Increased Longevity • Prevention of • CV mortality • Cancer mortality • CVD incidence • Metabolic syndrome • Diabetes • Dementia • Depression • Highly palatable! • Scarcity of large randomized trials

  7. Int J Epidemiol 2006;35:1417-22. BMJ 2008;336:1348 SUN BMJ 2008;337:a1344 Mediterranean Food pattern • Rapidly increasing evidence • Increased Longevity • Prevention of • CV mortality • Cancer mortality • CVD incidence • Metabolic syndrome • Diabetes • Dementia • Depression • Highly palatable! • Scarcity of large randomized trials

  8. de Lorgeril M, Salen P, Martin JL, et al. Final Report of the Lyon Diet Heart Study. Circulation 1999;99:779-785.

  9. Eur J Epidemiol 2004;19:9-13. • What is the MeDiet? • Olive oil as the main added lipid • Unrestricted Total Fat • MUFA-rich diet in the intervention group • Low consumption of meat / meat products • and what it is NOT the MeDiet • Margarine, soybean oil, mustard oil...

  10. de Lorgeril et al. Lyon trial. Circulation 1999;99:779-785. • Diet assessed in • ~30% of control • ~50% of experimental No biochemical confirmation of adherence. Trial stopped after 27 months. Low number of observed endpoints (14 vs. 44).

  11. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  12. Funding agency Network RD 06/0045 www.isciii.es Consortium (CIBER-OBN)

  13. Funding History # centers Network RD 06/0045 Initial Network Consortium ciberobn

  14. Centers • 11 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 8 ONLY-LAB GROUPS • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo

  15. Funded by network (RD 06/0045) • 6 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 7 LAB-ONLY GROUPS • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo ~750,000 $/yr

  16. Funded by consortium (ciberobn) • 5 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Sevilla- J Lapetra • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto • 1 LAB-ONLY GROUP • Barcelona-1- E Ros • Sevilla- V Ruiz-Gutierrez • Barcelona-2- RM Lamuela-Raventos • Navarra- JA Martinez • Valencia- G Saez • Barcelona-3- MT Mitjavila • Mallorca- JA Tur • Vitoria- MP Portillo ~1 M $/yr

  17. 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

  18. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

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

  20. PREDIMED Participants • 11 RECRUITMENT GROUPS • Navarra- MA Martinez-Gonzalez • Valencia- D Corella • Reus- J Salas-Salvado • Mallorca- M Fiol • Málaga- E Gomez-Gracia • Barcelona-1- R Estruch • Sevilla- J Lapetra • Vitoria- F Aros • Barcelona-2- MI Covas • Las Palmas- L Serra-Majem • Barcelona-3- X Pinto

  21. Project Leader: Dr. Ramón Estruch E Ros Clinic, Barcelona R Estruch Clinic, Barcelona E Gomez-Gracia Univ Málaga

  22. PREDIMED Participants

  23. PREDIMED: primary end-point Either: • cardiovascular death • myocardial infarction • stroke

  24. PREDIMED: Secondary end-points • total mortality • heart failure • major cancers • diabetes • dementia • We will also ascertainintermediate outcomes: • blood pressure (BP) • fasting blood glucose • lipid profile • markers of inflammation • other markers of CVD

  25. Virgin olive oil PREDIMED: intervention Introduce changes in the overall food pattern • Mediterranean diet: 2 groups • Total Fat: ad libitum • High in • MUFA (virgin olive oil) • Fish • Fruits, vegetables, legumes • Low in meats & dairy • alcohol permitted: wine • Low-fat diet - Control • Reduce every fat • Increase CHO • No Energy limitation tocopherols polyphenols flavonoids phytosterols

  26. Ann Intern Med 2006;145:1-11 Appendix, table 1 (on-line) 14-point score • Olive oil main culinary fat 8. Wine >=3 glasses/wk • Olive oil >=4 tablespoons/d 9. Legumes >=3/wk • Vegs>=2 serv./d 10. Fish & seafood >=3/wk • Fruits>=3 serv./d11. Cakes, sweets <3/wk • Red meats<1/d 12. Nuts >=1/wk • Butter, marg, cream<1/d 13. Poultry> red meats • Soda drinks<1/d14. Sofrito

  27. Strategies for behavior change • Repeated personal contacts: every 3-mo • Group sessions: every 3-mo • Holistic approach • Written information • Self-monitoring • Individualized goal-setting • Quick feedback • Individual motivational interviews (every 3-mo) • adapted to the patient’s features • clinical condition • preferences • beliefs • expressed in servings/d to improve understanding

  28. 1 l/week 30 g/day Strategies for behavior change-2 • Additional strategies • Seasonal buying lists • Menus and recipes • Only in the 2 MeDiet groups • Provision of key food items for free

  29. Special emphasis • Negotiated goal setting • Contracted agreement • Understandable: units=servings • Options for the negotiation • Serving size • Frequency of consumption • Way of cooking

  30. Group sessions

  31. Projected follow-up = 6 years (median)

  32. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo(Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  33. 3-mo changes Ann Intern Med 2006;145:1-11

  34. 3-mo changes in RF • 772 participants (55-80 yr) • Randomization: • 257 to a MeDiet + (free provision of olive oil) • 258 to a MeDiet + (free provision of nuts) • 257 to a LFD (control group) • Follow-up: 3 months • Nutrient profile and food items consumption • Mediterranean score (14-point score) • Classical risk factors • Novel risk factors (CRP, IL6, VCAM, ICAM)

  35. 3-mo changes in RF

  36. 3-mo changes in diet

  37. 3-mo changes in Risk Factors p<0.001 p=0.048 p<0.001 p=0.001 p<0.001 p=0.006

  38. 3-mo changes in Risk Factors p<0.001 p=0.017 p<0.001 p=0.022 p=0.039

  39. 3-mo changes in Risk Factors p<0.001 p<0.001 p=0.37 p=0.002 p<0.001 p=0.84

  40. 3-mo changes in Risk Factors

  41. 3-mo changes in Risk Factors

  42. 3-mo changes in Risk Factors

  43. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • Diet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  44. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9

  45. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9 • 339 men and 433 women (55-80 yr) • Exposure: • Food groups (137-item FFQ) • MeDiet adherence (14-point score) • Outcomes: • hs-C Reactive protein • interleukin-6 (IL-6) • intracellular adhesion molecule-1 (ICAM-1) • vascular cell adhesion molecule-1 (VCAM-1)

  46. Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9 *Adjusted for age, gender, diabetes, smoking, BMI, educational level, use of statins, NSAID, and aspirin. **Test for linear trend (multivariate adjusted)

  47. 8 IL-6 (pg/ml) CRP (mg/l) 7 6 5 4 3.59 3.51 3 3.18 2 1 0 <7 7 to 10 >10 MeDiet score (0-14) Salas-Salvado et al, Eur J Clin Nutr 2008;62:651-9

  48. PREDIMED TRIAL • Rationale • Funding sources • Methods and intervention protocol • Pilot study: Risk Factors at 3-mo (Ann Intern Med 2006) • Cross-sectional assessments: • MeDiet & inflammatory markers (Eur J Clin Nutr 2007) • MeDiet & risk factors (Eur J CV Prev 2008) • 3-mo changes in oxLDL (Arch Intern Med 2008) • 1-yr changes in diet (J Am Diet Assoc 2008) • 1-yr changes in MetS (Arch Intern Med 2008) • Other nested sub-studies

  49. All of them together Sánchez-Tainta, et al. Eur J Cardiovasc Prev Rehabil. 2008;15:589-93. • 3204 participants • Exposure: MeDiet (14-point score) • Adherence: Above Median (9) in the score • Ordered categories (5) in the score • Outcomes: • Diabetes • Hypertension • Obesity • Hypercholesterolemia

  50. MeDiet (>Median) and prevalence of Risk Factors Sánchez-Tainta, et al. Eur J Cardiovasc Prev Rehabil. 2008;15:589-93. Adjusted for age, gender, leisure-time physical activity (tertiles), smoking (5 categories), marital status (4 categories), educational level (4 categories), and BMI (3 categories, except when using obesity as outcome).

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