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Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery

2026年6月26日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：PEALut® + Standard of Care
Participants receive co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml) in addition to Standard of Care
他の：標準治療
標準治療
ダイエットサプリメント：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
他の名前：
  • グリアリア®経口懸濁液
  • PEALut® oral suspension
アクティブコンパレータ：Standard of Care
Participants receive only the Standard of Care
他の：標準治療
標準治療

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in cognitive performance
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Postoperative Cognitive Dysfunction (POCD)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
Plasma levels of phosphorylated tau (p-tau217) will be measured in blood samples using standard clinical laboratory assays.
Baseline
Plasma Aβ42 levels
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fondazione IRCCS San Gerardo dei Tintori

捜査官

  • 主任研究者：Giuseppe Bellelli、School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月2日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PEGASUS COG

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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