Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol

• Published in: BMC psychiatry Vol. 19; no. 1; pp. 63 - 7
• Main Authors: Sánchez-Villegas, A., Cabrera-Suárez, B., Molero, P., González-Pinto, A., Chiclana-Actis, C., Cabrera, C., Lahortiga-Ramos, F., Florido-Rodríguez, M., Vega-Pérez, P., Vega-Pérez, R., Pla, J., Calviño-Cabada, M. J., Ortuño, F., Navarro, S., Almeida, Y., Hernández-Fleta, J. L.
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 11.02.2019; BioMed Central; BMC
• Subjects: Analysis; Clinical trial; Clinical trials; Depression (Mood disorder); Depression - diet therapy; Depression - prevention & control; Depressive Disorder - diet therapy; Depressive Disorder - prevention & control; Diet; Diet, Mediterranean; Dietary Supplements; Epidemiology; Exercise; Extra-virgin olive oil; Female; Food habits; Health aspects; Humans; Internet software; Male; Medical research; Mediterranean diet; Mental depression; Middle Aged; Olive Oil; Physical activity; Prevalence studies (Epidemiology); Prevention; Psychiatrists; Psychiatry; Psychologists; Quality of Life; Randomized Controlled Trials as Topic; Recurrence (Disease); Recurrence of depression; Risk factors; Secondary Prevention; Study Protocol; Urine; Spain; Clinical trial; Recurrence of depression; Mediterranean diet; Extra-virgin olive oil
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-019-2036-4

The role of dietary patterns in the prevention of unipolar depression has been analyzed in several epidemiological studies. The primary aims of this study are to determine the effectiveness of an extra-olive oil-enriched Mediterranean diet in reducing the recurrence of depression and improving the symptoms of this condition. Multicenter, two-arm, parallel-group clinical trial. Arm 1, extra-virgin olive oil Mediterranean diet; Arm 2, control group without nutritional intervention. Dieticians are in charge of the nutritional intervention and regular contact with the participants. Contacts are made through our web platform ( https://predidep.es/participantes/ ) or by phone. Recurrence of depression is assessed by psychiatrists and clinical psychologists through clinical evaluations (semi-structured clinical interviews: Spanish SCID-I). Depressive symptoms are assessed with the Beck Depression Inventory. Information on quality of life, level of physical activity, dietary habits, and blood, urine and stool samples are collected after the subject has agreed to participate in the study and once a year. To the best of our knowledge, the PREDI-DEP trial is the first ongoing randomized clinical trial designed to assess the role of the Mediterranean diet in the prevention of recurrent depression. It could be a cost-effective approach to avoid recurrence and improve the quality of life of these patients. The study has been prospectively registered in the U.S. National Library of Medicine ( https://clinicaltrials.gov ) with NCT number: NCT03081065.