Clinical trial NCT07009223: Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
Official title: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Physical Activity
Inflammation
Metabolome
Gut Microbiota
Depressive Symptoms
Keywords: Depression
Cognition
nutrition
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: Amsterdam University Medical Centres (AUMC)
name: University of Milan
name: China Medical University, China
name: University College Cork
name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2025-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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);
* No cognitive impairment or mild functional impairment (MMSE \> 24)
* Ability to provide written informed consent.

Exclusion Criteria:

* Active gastrointestinal disorders;
* Autoimmune disorders;
* Chronic inflammatory disorders;
* Diagnosis of dementia;
* Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.

Primary outcomes:
measure: MADR Scale for Depression
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: PHQ-9
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: GDS-15
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: WHOQOL-BREF
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: RBANS
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: TMT
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: DSST
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: M-WCST
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
Secondary outcomes:
measure: Immunitary-related factors levels
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
measure: Gut Microbiome Composition
timeFrame: Baseline, Week 12, and 3-month follow-up (Week 24)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study officials:
References: