For Depression
What the SMILES trial actually showed
The SMILES trial: 32 percent remission vs 8 percent in control. NNT 4.1. Here's what it actually showed, what it didn't, and why it changed the field.
Robbie Rensel
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In 2017, Felice Jacka and her colleagues at Deakin University published a trial in BMC Medicine that changed the clinical conversation about food and mental health.
The SMILES trial — Supporting the Modification of lifestyle In Lowering Elevated cholesterol and major depressive disorder, an acronym that somewhat obscures what it actually was — enrolled 67 adults with current, diagnosed major depressive disorder. It randomized them to either a Mediterranean-style dietary intervention supported by seven sessions with a dietitian over twelve weeks, or a matched social support control: equal contact time, equal attention, equal care, but focused on conversation rather than food.
At twelve weeks, the dietary group showed 32 percent remission from major depression. The social support control showed 8 percent. The number needed to treat was 4.1 — meaning that for every four people who followed this dietary pattern with dietitian support, one achieved remission who would not have otherwise. In clinical terms, that is a meaningful effect size, comparable to what many pharmaceutical trials report.
The dietary group also reduced their food costs. Eating a Mediterranean-style diet was cheaper than their previous patterns. And the effect was not explained by weight loss, by increased physical activity, or by the social contact of the sessions themselves — the control matched those variables.
This trial mattered because it answered the basic question that any clinical intervention has to answer: does this actually help, in a controlled setting, compared to doing something else instead? The answer was yes.
But here is what it didn't show — and being precise about this matters.
It did not show that food cures depression. 32 percent remission means 68 percent did not achieve remission. The other outcome — 8 percent in the control — tells you that some people improve without the dietary intervention too. What the trial established is a treatment effect: the dietary pattern caused clinically meaningful improvement in a meaningful fraction of people.
It did not show which components of the Mediterranean pattern were responsible. Was it the fatty fish? The reduction in ultra-processed food? The olive oil? The increase in fiber? The fermented dairy? Probably all of them, working together — which is exactly what dietary pattern research shows again and again.
It did not show that food alone is sufficient treatment. All participants were receiving standard care. The dietary intervention was adjunctive — layered on top of whatever they were already doing. That is how Simmerstate positions food: as the nutritional layer supporting the clinical work, not as a replacement for it.
HELFIMED, published two years later, replicated the direction. Subsequent trials have continued to accumulate. The field has moved from establishing that food matters to establishing how to deploy it.
Simmerstate is built on this trajectory.