Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT07009223

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

Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2026-02-11

120

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

I

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Lead Sponsor

A

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 50 and 80 years
  • Diagnosis of major depressive disorder according to DSM-5 or depressive symptoms with PHQ-9 or GDS-15 score of 5 or higher
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy, 25125

Actively Recruiting

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Research Team

E

Elisa Mombelli

CONTACT

M

Moira Marizzoni, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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