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Comparison of an energy-reduced mediterranean diet and physical activity versus an ad libitum mediterranean diet in the prevention of type 2 diabetes: a secondary analysis of a randomized controlled trial
Ruiz-Canela M, Corella D, Martinez-Gonzalez MA, Babio N, Martinez JA, Forga L, Alonso-Gomez AM, Warnberg J, Vioque J, Romaguera D, Lopez-Miranda J, Estruch R, Santos-Lozano JM, Serra-Majem L, Bueno-Cavanillas A, Tur JA, Martin-Sanchez V, Riera-Mestre A, Delgado-Rodriguez M, Matia-Martin P, Vidal J, Vazquez C, Daimiel L, Buil-Cosiales P, Shyam S, Sorli JV, Castaner O, Garcia-Rios A, Torres-Collado L, Gomez-Gracia E, Zulet MA, Konieczna J, Casas R, Cano-Ibanez N, Tojal-Sierra L, Bernal-Lopez RM, Toledo E, Garcia-Gavilan J, Fernandez-Carrion R, Goday A, Arenas-Larriva AP, Gonzalez-Palacios S, Schroder H, Ros E, Fito M, Hu FB, Tinahones FJ, Salas-Salvado J
Annals of Internal Medicine 2025 Oct;178(10):1378-1389
clinical trial
This trial has not yet been rated.

BACKGROUND: Limited research has been done to evaluate the combined effect of energy reduction, Mediterranean diet (MedDiet), and physical activity on type 2 diabetes incidence. OBJECTIVE: To evaluate whether an energy-reduced MedDiet (erMedDiet) plus physical activity reduces diabetes incidence compared with a standard MedDiet. DESIGN: Prespecified secondary outcome analysis in the PREDIMED (Prevencion con Dieta Mediterranea)-Plus randomized, single-blinded, controlled trial. (ISRCTN Registry: ISRCTN89898870). SETTING: 23 centers across Spain. PARTICIPANTS: 4746 adults aged 55 to 75 years with metabolic syndrome and overweight or obesity, without prior cardiovascular disease or diabetes. INTERVENTION: Participants were randomly assigned 1:1 to an intervention group receiving an erMedDiet (planned reduction of 600 kcal per day), increased physical activity, and behavioral strategies for reducing weight, or a control group receiving ad libitum MedDiet advice. MEASUREMENTS: Diabetes incidence was based on the American Diabetes Association criteria. Anthropometric measurements were obtained annually. Cox regression models were used to assess the intervention effect. RESULTS: The 6-year absolute risk was 12.0% (95% CI 11.9% to 12.1%) in the control group (349 cases) and 9.5% (CI 9.4% to 9.5%) in the intervention group (280 cases). Over a median 6-year follow-up, diabetes incidence was 31% (CI 18% to 41%) relatively lower in the intervention group compared with the control group, with an absolute risk reduction of -2.6 cases (CI -2.7 to -2.4) per 1000 person-years. The intervention group attained better adherence to the erMedDiet, higher physical activity levels, and greater reductions in body weight and waist circumference. LIMITATION: Secondary outcome, single-blinded design, and self-reported dietary adherence. CONCLUSION: An intensive intervention with the MedDiet adding caloric reduction, physical activity, and modest weight loss was more effective than only an ad libitum MedDiet in reducing diabetes incidence in overweight/obese persons with metabolic syndrome. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III.

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