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

Study acronym: POWER
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 11, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Oct 1, 2025
    • Site details revised
    • Eligibility criteria shortened, about 4 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07009223
Lead Sponsor IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), University of Milan, China Medical University, China, University College Cork, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions
(from sponsor)
Major Depressive Disorder (MDD), Physical Activity, Inflammation, Metabolome, Gut Microbiota, Depressive Symptoms
Related terms Depression, Inflammation, Major Depressive Disorder, Motor Activity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov