Creatine and Perioperative Brain Health

Официальное название

Creatine Intervention in Older Adults to Improve Perioperative Brain Health

Обзор

The overall goal of this study is to evaluate the feasibility of perioperative oral creatine supplementation and to explore its effects on cognitive function and physiological responses to surgery in older adults. Creatine is commonly used to enhance athletic performance, but it can also have positive effects on the brain. Since surgery can alter thinking, memory, and attention patterns in some patients, we will assess whether creatine affects these changes in older adults undergoing surgery.

Подробное описание

Surgical interventions, while often necessary, are associated with substantial postoperative morbidity, particularly among older adults. Perioperative neurocognitive disorders (PND), characterized by changes in memory patterns in the perioperative period, are among the most common surgical complications in aging populations. Beyond their considerable economic burden, estimated to exceed $30 billion annually, PND imposes profound immediate consequences for patients and caregivers and is associated with long-term adverse outcomes, including an increased risk of dementia. Despite their high prevalence and clinical impact, effective, scalable, and easily implementable preventive strategies for PND remain limited.

Creatine plays a critical role in supporting the brain's high metabolic demands, and its homeostasis may be disrupted during periods of physiological stress such as anesthesia and surgery. Creatine supplementation has been demonstrated to be neuroprotective in high-stress conditions. However, the potential effects of creatine during perioperative cognitive vulnerability have not been previously investigated. This study will evaluate the feasibility of creatine supplementation in the perioperative period and explore its effects on cognitive function and physiological responses to surgery in older adults.

Вмешательства

• Пищевая добавка Creatine monohydrate
  Participants will receive creatine supplementation before surgery
• Другое Placebo
  Participants in the placebo group will receive an identical placebo before surgery

Первичные конечные точки

• Preoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Срок оценки: Within three weeks before surgery]
• Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Срок оценки: Within one month after surgery]
• Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Срок оценки: Within three months after surgery]
• Postoperative delirium assessed with the Confusion Assessment Method (CAM) [Срок оценки: Up to 7 days after surgery]

Критерии участия

Критерии включения

• Patients scheduled for elective surgery under general anesthesia

Критерии исключения

• History of creatine deficiency disorders
• Renal or neurodegenerative disorders
• History of stroke or significant head trauma, presence of intracranial mass lesions
• Inability to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07310043 · 2025P002111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗