Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression

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.

NCT Number	NCT06990035
Lead Sponsor	IRCCS Centro San Giovanni di Dio Fatebenefratelli
Conditions	Major Depressive Disorder (MDD)
Enrollment	120 participants
Start Date	2025-07
Primary Completion	2026-02 (estimated)
Study Completion	2026-02 (estimated)
Updated on ClinicalTrials.gov	2025-05-25