BackgroundAlthough the long-term health benefits of the Mediterranean diet are well established, its efficacy for weight loss at ≥12 months in overweight or obese individuals is unclear. We therefore conducted a systematic review of randomized controlled trials (RCTs) to determine the effect of the Mediterranean diet on weight loss and cardiovascular risk factor levels after ≥12 months. MethodsWe systematically searched MEDLINE, EMBASE, and the Cochrane Library of Clinical Trials for RCTs published in English or French and with follow-up ≥12 months that examined the effect of the Mediterranean diet on weight loss and cardiovascular risk factor levels in overweight or obese individuals trying to lose weight. ResultsFive RCTs (n = 998) met our inclusion criteria. Trials compared the Mediterranean diet to a low-fat diet (4 treatment arms), a low-carbohydrate diet (2 treatment arms), and the American Diabetes Association diet (1 treatment arm). The Mediterranean diet resulted in greater weight loss than the low-fat diet at ≥12 months (range of mean values: −4.1 to −10.1 kg vs 2.9 to −5.0 kg), but produced similar weight loss as other comparator diets (range of mean values: −4.1 to −10.1 kg vs −4.7 to −7.7 kg). Moreover, the Mediterranean diet was generally similar to comparator diets at improving other cardiovascular risk factor levels, including blood pressure and lipid levels. ConclusionOur findings suggest that the Mediterranean diet results in similar weight loss and cardiovascular risk factor level reduction as comparator diets in overweight or obese individuals trying to lose weight.