Clinical trial
PREDIMED (Mediterranean Diet)
Last updated Sat May 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Design
7,447 Spanish adults at high cardiovascular risk (T2D or three or more risk factors) randomised to:
- Mediterranean diet + extra-virgin olive oil (1 L/week supplied free).
- Mediterranean diet + 30 g/day mixed nuts (supplied free).
- Low-fat diet (control).
Median follow-up 4.8 years. Trial was retracted and republished in 2018 after methodological concerns; reanalysis preserved the headline findings.
Findings
- Primary composite (MI, stroke, CV death):
- EVOO arm: 31% relative reduction.
- Nuts arm: 28% reduction.
- Both significantly better than control.
- Stroke alone: 39–46% reduction.
- All-cause mortality: trend but not significant.
- Excellent safety; very high adherence to the dietary patterns.
Why it matters
PREDIMED was the first large RCT to show that a dietary pattern can reduce hard cardiovascular events in primary prevention — supporting decades of observational data and validating Mediterranean-style eating as evidence-based medicine.
Caveats
The 2018 retraction-republication corrected statistical analysis but preserved conclusions. PREDIMED-Plus extends the study with an energy-reduced Mediterranean diet plus exercise targeting weight loss — results emerging.
Related entries
Mediterranean diet, Extra virgin olive oil, Nuts, Cardiovascular disease.
References
- Estruch, R. et al. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. N. Engl. J. Med. 378, e34 (2018).