Feb 25, 2013 (Epub ahead of print

Initial research teamG 03/140

RD 06/0045CIBERobn

www.predimed.es

Food industry: only food items

Provision of Olive oil~2 000 l/wk

Provision of nuts30 kg/wk walnuts15 kg/wk almonds

Men: 55-80 yr Women: 60-80 yr High CV risk without CVD

type 2 diabetics

3+ risk factors

PREDIMED TRIAL: DESIGN

Random

1. Smoking

2. Hypertension

3. LDL

4. HDL

5. Overweight/obes

6. Family history

Recruitment: primary care

N= 7,447

www.predimed.es

Random

Primary end-point: either –cardiovascular death

–myocardial infarction

–stroke

www.predimed.es

PREDIMED: interventionIntroduce 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 restriction– No specific recommendation on Physical Activity

tocopherols polyphenols flavonoids phytosterols

www.predimed.es

What is the Mediterranean diet?

1. Olive oil main culinary fat2. Olive oil >=4 tablespoons/d 3. Vegetables>=2 serv./d

4. Fruits>=3 serv./d5. Red meats<1/d

6. Butter, marg, cream<1/d7. Soda drinks<1/d

8. Wine >=7 glasses/wk9. Legumes >=3/wk10. Fish & seafood >=3/wk11. Cakes, sweets <3/wk12. Nuts >=3/wk13. Poultry > red meats14. Sofrito >=2/wk

14-itemscreener

Martínez-Gonzalez et al. Int J Epidemiol 2012;41:377

Sofrito

3

August 2012 Volume 7 Isue 8 e43134

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

Additional strategies– Seasonal buying lists–Menus and recipes

Only in the 2 MeDiet groups• Provision of key food items

for free

Negotiated goal setting• Contracted agreement• Understandable: units=servings

Options for the negotiation• Serving size• Frequency of consumption• Way of cooking

3-yr attainments (%) for each of the 14 items

0

10

20

30

40

50

60

70

80

90

100

MeDiet + Virgin olive oil

MeDiet + mixed nutsControl group

-2

-1

0

1

2

3

4

5

6

7

Energy x 1000 Kcal

Prot (%E)

CHO (%E)

Fiber (g/d)

Fat (%E)

SFA (%E)

MUFA (%E)

PUFA (%E)

Nuts (%E)

Olive O. (%E)

FFQ: Changes in Energy, Nutrient and Supplemental Food Intake by Study Arm

p<.001 except fiber (p=0.10) & SFA (p=0.004) p<.001 except SFA (p=0.30)

MeDiet + Virgin olive oil

MeDiet + mixed nutsControl group

Urinary hydroxytyrosol concentrations (95% confidence intervals) at baseline and at 1, 3 and 5

years of follow-up (N = 750).

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).

N Engl J Med 2013Suppl. Appendix

MeDiet+EVOO MeDiet+nuts Control0

2

4

6

8

10

12

8.1 8,0

11.2

Primary end-point (MI, stroke or death from CV causes)Crude rates / 1000 person-years N Engl J Med 2013

www.predimed.es

Unadjusted Adjusted (1) Addtionally-adj (2)

0.2

0.4

0.6

0.8

1

1.2

Haz

ard

Rat

ios

(95%

CI)

Unadjusted Adjusted (1) Additionally adj. (2)

0.2

0.4

0.6

0.8

1

1.2

Haz

ard

Rat

ios

(95%

CI)

Primary end-point

(1). Stratified according to recruiting center and adjusted for sex, age, family history of premature coronary heart disease, and smoking status.(2) Additionallly adjusted for body-mass index, waist-to-height ratio, hypertension at baseline, dyslipidemia at baseline, and diabetes at baseline.

N Engl J Med 2013

Primary end-point (MI, stroke or death from CV causes)

Stroke MI CV Death0.2

0.4

0.6

0.8

1

1.2

1.4

Haz

ard

Rat

ios

(95%

CI)

Stroke MI CV death0.2

0.4

0.6

0.8

1

1.2

1.4

Haz

ard

Rat

ios

(95%

CI)

Secondary end-points

Stratified according to recruiting center and adjusted for sex, age, family history of premature coronary heart disease, and smoking status, body-mass index, waist-to-height ratio, hypertension at baseline, dyslipidemia at baseline, and diabetes at baseline.

N Engl J Med 2013

Total mortality