Lifestyle makeover may shield aging brains from Depression-Linked decline
NCT ID NCT07009223
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether lifestyle changes—like following a Mediterranean diet, exercising regularly, or doing cognitive training—can prevent cognitive decline and improve mood in people aged 50 to 80 who have depressive symptoms or major depression but no current memory problems. Researchers will compare three groups over 12 weeks, measuring changes in depression, quality of life, and thinking skills. They will also look at how these changes affect gut bacteria and inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mediterranean diet, physical activity, and cognitive training
- What this could lead to
- If successful, this could show that simple lifestyle changes like diet and exercise help protect memory and thinking skills in older adults with depression.
- What could go wrong
- This is a small, early-stage study (120 people) testing multiple interventions, so results may not apply broadly. It also relies on participants sticking to the programs, which can be challenging.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Centro San Giovanni di Dio Fatebenefratelli
RECRUITINGBrescia, 25125, Italy
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