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Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery

26 czerwca 2026 zaktualizowane przez: Fondazione IRCCS San Gerardo dei Tintori

Palmitoylethanolamide/Luteolin for the Maintenance of Cognitive Performance in Older Adults Undergoing Cardiac Surgery

Postoperative Cognitive Dysfunction (POCD) is a common complication after surgery, particularly among older adults. It is characterized by cognitive impairment, reduced functional independence, and decreased quality of life. Growing evidence suggests that neuroinflammation plays a relevant role in POCD development and persistence.

Palmitoylethanolamide (PEA) is an endogenous lipid mediator involved in the regulation of neuroinflammatory processes through the modulation of non-neuronal cells, while luteolin is a flavonoid with well-known antioxidant properties. Under conditions of prolonged neuroinflammation, endogenous PEA levels may be insufficient to adequately counteract pro-inflammatory signaling, making exogenous administration necessary.

In this context, exogenous micronized and ultramicronized PEA (mPEA and umPEA) supplementation has been shown to modulate cognitive and executive functions, working memory, language, and activities of daily living. Moreover, the combination of umPEA and luteolin (PEALut) may produce synergistic effects by modulating neuroinflammation and supporting neuronal function.

This study aims to evaluate whether postoperative administration of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 mL), added to standard of care, may contribute to the mitigation of POCD in older adults undergoing elective cardiac surgery, compared to standard care alone.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PEALut® + Standard of Care
Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care
Inny: Standard opieki
Standard opieki
Suplement diety: co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml)
Oral suspension, 10 ml twice daily (every 12 hours), starting within 24 hours post-surgery and for 3 months, in add-on to the Standard of Care
Inne nazwy:
  • Glialia® zawiesina doustna
  • PEALut® oral suspension
Aktywny komparator: Standard of Care
Participants receive only the Standard of Care
Inny: Standard opieki
Standard opieki

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in cognitive performance
Ramy czasowe: Baseline, hospital discharge (approximately postoperative day 7-10, depending on clinical course), 3 months after treatment, and 3 months after the end of treatment
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-item screening tool that evaluates multiple cognitive domains, including memory, visuospatial ability, executive function, attention, language, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Baseline, hospital discharge (approximately postoperative day 7-10, depending on clinical course), 3 months after treatment, and 3 months after the end of treatment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Postoperative Cognitive Dysfunction (POCD)
Ramy czasowe: Hospital discharge (approximately postoperative day 7-10, depending on clinical course), and 3 months after treatment
Incidence of POCD will be defined as a decrease of at least 1 standard deviation from baseline MoCA score.
Hospital discharge (approximately postoperative day 7-10, depending on clinical course), and 3 months after treatment
Incidence, subtype and duration of postoperative delirium (POD)
Ramy czasowe: Daily, from 24 hours after the intervention until hospital discharge (approximately postoperative day 7-10, depending on clinical course)
Postoperative delirium will be assessed using the 4AT screening tool. A score of ≥4 suggests possible delirium (with or without cognitive impairment), with higher scores indicating greater severity of cognitive disturbance. Positive screenings will be confirmed using DSM-5 criteria. Delirium subtype will be classified using the Delirium Motor Subtyping Scale-4 (DMSS-4), and duration will be recorded in days from onset to resolution.
Daily, from 24 hours after the intervention until hospital discharge (approximately postoperative day 7-10, depending on clinical course)
Change in Activities of Daily Living (ADL)
Ramy czasowe: Baseline, 3 months after treatment, and 3 months after the end of treatment
Activities of daily living will be assessed using the six-item Katz Activities of Daily Living (ADL) Index. Scores range from 0 to 6, with higher values indicating greater function.
Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Instrumental Activities of Daily Living (IADL)
Ramy czasowe: Baseline, 3 months after treatment, and 3 months after the end of treatment
Functional status will be assessed using the Instrumental Activities of Daily Living (IADL) scale. Scores range from 0 to 8, with higher scores indicating better functional ability.
Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Short Physical Performance Battery (SPPB)
Ramy czasowe: Baseline, 3 months after treatment, and 3 months after the end of treatment
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and chair stand performance. Scores range from 0 to 12, with higher scores indicating better physical performance.
Baseline, 3 months after treatment, and 3 months after the end of treatment
Change in Handgrip Strength
Ramy czasowe: Baseline, 3 months after treatment, and 3 months after the end of treatment
Muscle strength will be assessed using a handgrip dynamometer. Handgrip strength will be recorded in kilograms (kg), with higher values indicating greater muscle strength.
Baseline, 3 months after treatment, and 3 months after the end of treatment
Rehospitalization
Ramy czasowe: From 24 hours after the intervention to 6 months after randomization
Incidence of rehospitalization
From 24 hours after the intervention to 6 months after randomization
Mortality
Ramy czasowe: From 24 hours after the intervention to 6 months after randomization
Incidence of mortality
From 24 hours after the intervention to 6 months after randomization
Incidence of Treatment-Related Adverse Events
Ramy czasowe: From first treatment administration up to 3 months after the end of treatment
Safety and Adherence assessment will be assessed by monitoring the incidence and severity of adverse events occurring during the study period.
From first treatment administration up to 3 months after the end of treatment
Plasma p-tau217 levels
Ramy czasowe: Baseline
Plasma levels of phosphorylated tau (p-tau217) will be measured in blood samples using standard clinical laboratory assays.
Baseline
Plasma Aβ42 levels
Ramy czasowe: Baseline
Plasma levels of Amyloid beta 42 (Aβ42) will be measured in blood samples using standard clinical laboratory assays.
Baseline
Change in plasma IL-6 levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Interleukin-6 (IL-6) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma s-RAGE levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of soluble Receptor for Advanced Glycation End-products (s-RAGE) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GDF-15 levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Growth Differentiation Factor-15 (GDF-15) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma GFAP levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Glial Fibrillary Acidic Protein (GFAP) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NSE levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Neuron-Specific Enolase (NSE) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma NfL levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Neurofilament Light Chain (NfL) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma FGF-1 levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Fibroblast Growth Factor-1 (FGF-1) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Change in plasma BDNF levels
Ramy czasowe: Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment
Plasma levels of Brain-Derived Neurotrophic Factor (BDNF) will be measured in blood samples using standard clinical laboratory assays.
Baseline, Immediately after surgery (within 24 hours, before PEALut administration), and 3 months after treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione IRCCS San Gerardo dei Tintori

Śledczy

  • Główny śledczy: Giuseppe Bellelli, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2027

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

11 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

2 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PEGASUS COG

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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