Healthy-lifestyle program to help with depression using the Mediterranean diet and activity
Official title: Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato
Run by IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT06990035 · Data updated 2026-11-12
This trial tests whether combining Mediterranean diet lessons with a structured physical activity program can help reduce depressive symptoms in people with major depressive disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 2 sites (Brescia, Italy and 1 other locations) |
| Status | Recruiting |
| Started | January 26, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06990035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with major depressive disorder who have lower than 150 minutes/week of moderate-intensity physical activity and can provide informed consent.
✕Probably not a fit
Individuals with severe psychiatric symptoms or medical conditions limiting physical activity may not benefit from the added exercise component.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with major depressive disorder are randomized to receive either Mediterranean diet education alone or Mediterranean diet education plus a 12-week physical activity program. The study will track changes in depressive symptoms and also explore biological changes, such as gut microbiota and inflammatory markers, related to the physical activity component. The aim is to see if adding exercise to dietary guidance provides additional benefit beyond diet education alone.
Why it matters
Potential benefit: If successful, participants may experience greater reductions in depressive symptoms and related biological changes associated with improved health.
How similar studies have gone: Previous work suggests lifestyle interventions targeting diet and activity can influence mood and biology, though the specific combination and measurements here are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013). * Depressive symptoms assessed using MADR, BDI, or ZDR scales. * Ability to provide written informed consent. * Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week. Exclusion Criteria: * Patients with severe psychopathology. * Medical contraindications to physical activity. * Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant. * Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months * Active gastrointestinal diseases * Autoimmune and/or chronic inflammatory disorders
Where it's running
-
IRCCS Centro San Giovanni fi Dio Fatebenefratelli
Brescia, Italy, Italy Recruiting -
Comunità Fraternità società cooperativa sociale ONLUS
Ospitaletto, Italy, Italy Recruiting
Study contacts
- Study coordinator: Annamaria Cattaneo, PhD
- Email: acattaneo@fatebenefratelli.eu
- Phone: 0039 030 3501599
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.