Life sciences · Interventional Study
ClinicalTrials.gov · October 27, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06990035). This is a study registration, not published results. Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD). Interventions: BEHAVIORAL: Mediterranean diet lessons program; BEHAVIORAL: Physical activity. Primary outcome measures: MADR Scale for Depression , Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).; Beck Depression Inventory - II , Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).; Zung Self-Rating Depression Scale , Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).; Personal and Social Performance Scale , Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).; World Health Organization Quality of Life - Bref , Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).. Brief summary: This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention. Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.