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Search / Trial NCT07009223

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

Launched by IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI · May 29, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Depression Cognition Nutrition

ClinConnect Summary

This clinical trial is looking at whether making lifestyle changes can help improve mood and memory in people aged 50 to 80 who have symptoms of depression but do not show signs of cognitive decline. The researchers want to see if regular exercise, healthy eating based on the Mediterranean diet, and cognitive training can prevent further mental difficulties and might even change gut health and inflammation levels in the body. Participants will be divided into groups to try out these different approaches, and their progress will be monitored over 12 weeks and again after three months.

To be eligible for the study, participants need to be between 50 and 80 years old and have a diagnosis of major depressive disorder or show depressive symptoms. They should not have any significant cognitive impairment and must be able to provide written consent. Throughout the trial, participants can expect to join online sessions about healthy eating, participate in supervised exercise, or take part in cognitive training in small groups. They will also provide blood and stool samples and complete some memory and mood tests to help researchers understand the effects of these lifestyle changes.

Gender

ALL

Eligibility criteria

  • 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);
  • No cognitive impairment or mild functional impairment (MMSE \> 24)
  • Ability to provide written informed consent.
  • Exclusion Criteria:
  • Active gastrointestinal disorders;
  • Autoimmune disorders;
  • Chronic inflammatory disorders;
  • Diagnosis of dementia;
  • Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.

About Irccs Centro San Giovanni Di Dio Fatebenefratelli

IRCCS Centro San Giovanni di Dio Fatebenefratelli is a leading research and clinical care institution in Italy, dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. As a recognized IRCCS (Istituto di Ricovero e Cura a Carattere Scientifica), the center emphasizes a multidisciplinary approach, integrating cutting-edge research with comprehensive healthcare services. With a strong commitment to ethical standards and patient safety, the institution collaborates with various stakeholders to foster advancements in medical knowledge and therapeutic practices, ultimately enhancing the quality of care provided to patients.

Locations

Brescia, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported