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

Recruiting now · Not applicable

Conditions studied: Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome, Gut Microbiota, Depressive Symptoms

In brief

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.

Key facts

Study ID

NCT07009223

Run by

IRCCS Centro San Giovanni di Dio Fatebenefratelli

People needed

120

Starts

2025-10-01

Expected to finish

2028-03-01

Last updated by the study team

2026-02-11

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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);
• Ability to provide written informed consent.

You may not qualify if…

• 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 prior to the screening visit.

Where it is running

• IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (enrolling)

Full record on ClinicalTrials.gov

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