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Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery

26. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PEALut® + Standard of Care
Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care
Jiný: Standartní péče
Standartní péče
Doplněk stravy: 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
Ostatní jména:
  • Glialia® perorální suspenze
  • PEALut® oral suspension
Aktivní komparátor: Standard of Care
Participants receive only the Standard of Care
Jiný: Standartní péče
Standartní péče

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in cognitive performance
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Postoperative Cognitive Dysfunction (POCD)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
Plasma levels of phosphorylated tau (p-tau217) will be measured in blood samples using standard clinical laboratory assays.
Baseline
Plasma Aβ42 levels
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Fondazione IRCCS San Gerardo dei Tintori

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2028

Termíny zápisu do studia

První předloženo

11. června 2026

První předloženo, které splnilo kritéria kontroly kvality

26. června 2026

První zveřejněno (Aktuální)

2. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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