Lifestyle changes to prevent memory problems in older adults with depression
Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
NA · IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT07009223
This trial will test whether a Mediterranean-style diet, regular supervised exercise, or weekly cognitive training can help prevent memory decline and improve mood in people aged 50–80 with depressive symptoms or major depression but no cognitive impairment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli (other) |
| Locations | 1 site (Brescia) |
| Trial ID | NCT07009223 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults aged 50–80 with major depressive disorder or depressive symptoms but without signs of cognitive decline and randomizes them to one of three lifestyle interventions: online Mediterranean diet education, supervised regular physical activity, or weekly cognitive training. Participants undergo behavioral programs plus scheduled clinical and cognitive testing, and provide blood and stool samples for inflammatory markers, metabolome analysis, and gut microbiota profiling. Investigators will compare mood and cognitive outcomes across the three groups and link clinical changes to biological measures to explore underlying mechanisms. Some sessions are delivered online while exercise supervision and biological sampling require in-person visits at the coordinating center.
Who should consider this trial
Good fit: Ideal candidates are adults 50–80 years old with a DSM-5 diagnosis of major depressive disorder or measurable depressive symptoms (PHQ-9 or GDS-15 ≥ 5), who can provide informed consent and have no cognitive impairment.
Not a fit: People with diagnosed dementia, existing cognitive impairment, active gastrointestinal, autoimmune, or chronic inflammatory disorders, or recent use of antibiotics or anti-inflammatory drugs are excluded or unlikely to benefit from the interventions.
Why it matters
Potential benefit: If successful, these accessible lifestyle approaches could reduce depressive symptoms, slow or prevent cognitive decline, and improve daily functioning and quality of life.
How similar studies have performed: Prior trials show that exercise, Mediterranean-style diets, and cognitive training can each benefit mood or cognition, but combined mechanistic studies linking these interventions to gut microbiota and inflammation remain relatively uncommon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 prior to the screening visit.
Where this trial is running
Brescia
- IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (RECRUITING)
Study contacts
- Study coordinator: Elisa Mombelli
- Email: emombelli@fatebenefratelli.eu
- Phone: (+39) 030 35 01 598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Physical Activity, Inflammation, Metabolome, Gut Microbiota, Depressive Symptoms, Depression, Cognition