Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice
NCT ID: NCT07009223
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-07-31
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
NCT06990035
A One-year Trajectory of Depression Status Changes in Older Adults With MCI and SD: a Longitudinal Cohort Study
NCT06308627
Lifestyle Medicine for Depression
NCT03720145
LIVES: Personalized Lifestyle Intervention for Patients With Depression
NCT05767073
The Relations Among Endotoxin, Inflammatory Cytokines, Cognitive Markers and Brain MRI Changes in Subjects With Depressive Disorder
NCT06203015
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Control group (CON)
Mediterranean Diet
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
Group 2: CON + physical activity
Mediterranean Diet
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
Physical Activity
In addition to educational sessions on the Mediterranean diet, there will be 2-3 weekly personalized exercise sessions, followed by a dedicated personal trainer at a partner gym. The treatment will last 12 weeks.
Group 3: CON + Cognitive training
Mediterranean Diet
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
Cognitive Training
In addition to educational sessions on the Mediterranean diet, there will be one weekly cognitive training session in groups, supervised by qualified staff at the IRCCS FBF. The treatment will last for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mediterranean Diet
Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.
Physical Activity
In addition to educational sessions on the Mediterranean diet, there will be 2-3 weekly personalized exercise sessions, followed by a dedicated personal trainer at a partner gym. The treatment will last 12 weeks.
Cognitive Training
In addition to educational sessions on the Mediterranean diet, there will be one weekly cognitive training session in groups, supervised by qualified staff at the IRCCS FBF. The treatment will last for 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
OTHER
University of Milan
OTHER
China Medical University, China
OTHER
University College Cork
OTHER
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CERP-2024-23685718
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.