Tests diet and exercise lessons for people with depression
Compares Mediterranean diet lessons with added physical activity in adults with depression.
Plain-language title generated from the registry record
Registry title: Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Key facts
- Where
- Brescia and Ospitaletto, ItalySee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 55 to 80 with a main diagnosis of depression who do little regular physical activity. It tests Mediterranean diet lessons with or without a 12-week exercise program.
- Age
- 55 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Main diagnosis of depression (DSM-5 criteria), with depressive symptoms measured on the MADR, BDI or ZDR scales.
- Earlier treatment
- People who had antibiotic or anti-inflammatory treatment in the last 3 months cannot join.
Main reasons for not taking part
- Severe psychopathology
- Medical reasons not to do physical activity
- Orthopedic problems or other conditions limiting the fitness assessment, or currently pregnant
- Antibiotic or anti-inflammatory treatment in the last 3 months
- Active gastrointestinal diseases, or autoimmune or chronic inflammatory disorders
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 80 years old?
Source: NCT06990035, who can take part
Where in Italy
- IRCCS Centro San Giovanni fi Dio FatebenefratelliBrescia, ItalyContact: Annamaria Cattaneo, PhDTaking people
- Comunità Fraternità società cooperativa sociale ONLUSOspitaletto, ItalyContact: Ezio CigognettiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Trial code
- NCT06990035
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato
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.
Inclusion: 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: Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant; Active gastrointestinal diseases; Autoimmune and/or chronic inflammatory disorders; Patients with severe psychopathology; Medical contraindications to physical activity; Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months.