RecruitingNot ApplicableNCT07009223

Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Enrollment

120 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Physical Activity Depressive Symptoms Inflammation Major Depressive Disorder (MDD)Gut Microbiota Metabolome

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lifestyle changes — such as diet, exercise, or gut microbiome support — can help protect brain health and prevent memory problems in older adults who have depression or depressive symptoms. **You may be eligible if...** - You are 50–80 years old - You have been diagnosed with depression or have notable depressive symptoms (based on a standard questionnaire) - You are able to give written informed consent **You may NOT be eligible if...** - You have been diagnosed with dementia or significant memory impairment - You have an autoimmune or chronic inflammatory condition - You have active digestive/gastrointestinal disorders - You have used antibiotics or anti-inflammatory drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMediterranean Diet

Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.

BEHAVIORALPhysical 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.

BEHAVIORALCognitive 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.