Actively Recruiting
Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2026-02-11
120
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
I
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Lead Sponsor
A
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 50 and 80 years
- Diagnosis of major depressive disorder according to DSM-5 or depressive symptoms with PHQ-9 or GDS-15 score of 5 or higher
- Ability to provide written informed consent
You will not qualify if you...
- Active gastrointestinal disorders
- Autoimmune disorders
- Chronic inflammatory disorders
- Diagnosis of dementia, cognitive impairment, or mild functional impairment
- Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Actively Recruiting
Research Team
E
Elisa Mombelli
CONTACT
M
Moira Marizzoni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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