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Can a natural supplement shield the aging brain from Surgery's mental fog?

NCT ID NCT07681063

Disease control Sponsor: Fondazione IRCCS San Gerardo dei Tintori Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a combination of palmitoylethanolamide and luteolin (PEALut), taken as an oral supplement for three months after heart surgery, can help prevent or reduce cognitive decline in adults aged 65 and older. The supplement aims to calm brain inflammation and oxidative stress, which are thought to contribute to postoperative cognitive dysfunction. Participants will be randomly assigned to receive either the supplement plus standard care, or standard care alone, and their thinking abilities will be tracked using memory and attention tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Palmitoylethanolamide and Luteolin (PEALut) oral suspension
What this could lead to
If it works, this could offer a simple, safe supplement to help older adults maintain their memory and thinking after heart surgery.
What could go wrong
This is a small, early-stage trial. The supplement may not prevent cognitive decline, and results may not apply to all types of surgery or patients.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 65 years * Both genders * Undergoing elective aortic or mitral valve replacement/reconstruction with or without coronary artery bypass grafting (CABG), at the Cardiac Surgery Unit of IRCCS San Gerardo dei Tintori Foundation (Monza, Italy) * Prognosis quoad vitam ≥ 3 months * Availability of a formal or informal caregiver who can assist the participant in taking the prescribed dose and following the visit schedule * Any concomitant therapy should be stable * Written informed consent obtained prior to randomization (from the participant or caregiver if the participant is unable to sign but clearly expresses the will to participate) Exclusion Criteria: * Severe dementia diagnosis * Preoperative clinical diagnosis of delirium * Other treatments/medications that may improve cognition * Current treatment with m/umPEA or PEALut (Glialia®), or its use within 90 days prior to enrollment * Contraindications to the use of PEALut, including allergy to excipients contained in the supplement and previous adverse reactions to PEALut * Other clinical conditions or situations that could interfere with the study or prevent optimal participation, as judged by the researchers

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Neuroinflammatory Diseases Postoperative Cognitive Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative cognitive dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy

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