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Introduction
PREDIMED (Prevención con Dieta Mediterránea) is a landmark clinical trial conducted in Spain.
The study made a huge splash due to the rarity in nutrition of having large RCTs with hard endpoints. In addition, it had results of a large magnitude; showing a 30% reduction in cardiovascular events.
But the study did face criticisms and controversies over methodological issues, including randomization procedures at certain centers, ultimately leading to a retraction of the original paper and a re-analysis.
Participants in the PREDIMED trial were randomly assigned to one of three groups:
- A Mediterranean diet supplemented with extra-virgin olive oil.
- A Mediterranean diet supplemented with mixed nuts (walnuts, almonds, and hazelnuts).
- A control group following a low-fat diet.
Despite the issues it still ends up being an incredibly useful source of data.
In this episode we discuss the findings from PREDIMED, some of the potential limitations, and where it sits among the wider Mediterranean Diet literature.
Related resources
- Join the Sigma newsletter for free
- Subscribe to Sigma Nutrition Premium
- Become a member of Alan Flanagan’s Alinea Nutrition Education Hub
- Further reading:
- [01:37]Common claims and narratives
- [03:15]Historical context of dietary guidelines
- [21:57]Sugar industry influence on dietary research
- Glucose Peaks
- Some Pragmatic Considerations
The Hosts
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Dr. Alan Flanagan has a PhD in nutrition from the University of Surrey, where his doctoral research focused on circadian rhythms, feeding, and chrononutrition.
This work was based on human intervention trials. He also has a Masters in Nutritional Medicine from the same institution.
Dr. Flanagan is a regular co-host of Sigma Nutrition Radio. He also produces written content for Sigma Nutrition, as part of his role as Research Communication Officer.
Danny Lennon has a master’s degree (MSc.) in Nutritional Sciences from University College Cork, and he is the founder of Sigma Nutrition.
Danny is currently a member of the Advisory Board of the Sports Nutrition Association, the global regulatory body responsible for the standardisation of best practice in the sports nutrition profession.
Introduction to this Episode
PREDIMED (Prevención con Dieta Mediterránea) is a landmark clinical trial conducted in Spain.
The study made a huge splash due to the rarity in nutrition of having large RCTs with hard endpoints. In addition, it had results of a large magnitude; showing a 30% reduction in cardiovascular events.
But the study did face criticisms and controversies over methodological issues, including randomization procedures at certain centers, ultimately leading to a retraction of the original paper and a re-analysis.
Participants in the PREDIMED trial were randomly assigned to one of three groups:
- A Mediterranean diet supplemented with extra-virgin olive oil.
- A Mediterranean diet supplemented with mixed nuts (walnuts, almonds, and hazelnuts).
- A control group following a low-fat diet.
Despite the issues it still ends up being an incredibly useful source of data.
In this episode we discuss the findings from PREDIMED, some of the potential limitations, and where it sits among the wider Mediterranean Diet literature.
PREDIMED – Quick Overview
Background Context:
- Original PREDIMED publication made a huge splash and has been highly cited. It was perhaps the most well known nutrition RCT (and still is), and published in a prestigious journal (NEJM).
- In addition to being a nutrition RCT, highly powered across multiple centers, it had large magnitude results: 30% reduction in CVD.
- However, there were some issues with the methodology that drew criticism and questions, and took the shine off the results to some degree. Indeed, the core publication was retracted and republished in 2018 as a non-randomised study.
- Despite that, if we acknowledge those limitations, it still ends up being an incredibly useful source of data.
