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

ClinicalTrials.gov IDNCT07009223

PhaseNA

Enrollment120

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Age50 Years – 80 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

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.

Primary outcomes

MADR Scale for Depression (Baseline, Week 12, and 3-month follow-up (Week 24))
PHQ-9 (Baseline, Week 12, and 3-month follow-up (Week 24))
GDS-15 (Baseline, Week 12, and 3-month follow-up (Week 24))
WHOQOL-BREF (Baseline, Week 12, and 3-month follow-up (Week 24))
RBANS (Baseline, Week 12, and 3-month follow-up (Week 24))
TMT (Baseline, Week 12, and 3-month follow-up (Week 24))
DSST (Baseline, Week 12, and 3-month follow-up (Week 24))
M-WCST (Baseline, Week 12, and 3-month follow-up (Week 24))

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, 25125 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.