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
82 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
Researchers are studying whether lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people aged 50 to 80 who have depressive symptoms or major depression but no signs of cognitive decline. The study aims to find out if regular physical activity improves mood and memory, if cognitive training prevents mental difficulties, and if diet and lifestyle changes affect gut bacteria and inflammation. Participants will be randomly assigned to one of three groups: one group will receive online education about the Mediterranean diet, another group will receive the diet education plus personalized exercise sessions 2 to 3 times per week for 12 weeks, and a third group will receive the diet education plus weekly cognitive training in small groups for 12 weeks. All groups will be followed for 12 weeks of treatment. During the study, participants will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the start, after 12 weeks of treatment, and again after a 3-month follow-up (week 24). Researchers will measure depression scales, cognitive performance tests, quality of life, immune-related factors, and gut microbiome composition throughout the study to assess changes over time.
CONDITIONS
Brief 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 indicated by PHQ-9 or GDS-15 scores 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 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive educational sessions about the Mediterranean diet. Depending on their group, they may also participate in physical activity sessions or weekly cognitive training sessions.
4 to 5 online educational sessions; 2 to 3 weekly exercise sessions for those in the physical activity group; 1 weekly cognitive training session for those in the cognitive training group
Duration - 12 weeks
Participants are monitored for changes in cognitive and depressive symptoms after completing the treatment.
1 visit at 3 months post-treatment
Trial Site Locations
Total: 1 location
1
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Actively Recruiting
Research Team
E
Elisa Mombelli
M
Moira Marizzoni, PhD
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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