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RECRUITING
NCT07009223
NA

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

Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-10-01

Completion Date

2028-03

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy