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Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery

26 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: PEALut® + Standard of Care
Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care
Autre: Norme de soins
Norme de soins
Complément alimentaire: 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
Autres noms:
  • Glialia® suspension buvable
  • PEALut® oral suspension
Comparateur actif: Standard of Care
Participants receive only the Standard of Care
Autre: Norme de soins
Norme de soins

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in cognitive performance
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of Postoperative Cognitive Dysfunction (POCD)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
Plasma levels of phosphorylated tau (p-tau217) will be measured in blood samples using standard clinical laboratory assays.
Baseline
Plasma Aβ42 levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fondazione IRCCS San Gerardo dei Tintori

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2028

Dates d'inscription aux études

Première soumission

11 juin 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PEGASUS COG

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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