NCT07009223Recruiting
Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline. The main questions it aims to answer are: * Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms? * Does cognitive training help prevent mental difficulties in people at risk of cognitive decline? * Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors? Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health. The participants: * Will take part to online sessions on healthy eating based on the Mediterranean diet * Some will do regular exercise, supervised by a personal trainer * Others will do weekly cognitive training in small groups at the hospital * They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 May 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Diseases
- Depression
- NCT number
- NCT07009223
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Oct 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.
Other illness
- Active gastrointestinal disorders;
- Autoimmune disorders;
- Chronic inflammatory disorders;
- Diagnosis of dementia; cognitive impairment or mild functional impairment.
Who the study is looking for
- Aged between 50 and 80 years;
- Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);
- Ability to provide written informed consent.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Centro San Giovanni di Dio Fatebenefratelli Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.