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NCT Number: NCT07310043

Creatine and Perioperative Brain Health

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective surgery under general anesthesia

Exclusion criteria

  • 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

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

Participants will receive creatine supplementation before surgery

Placebo

Other

Participants in the placebo group will receive an identical placebo before surgery

Primary outcomes

  1. Preoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)

    Time frame: Within three weeks before surgery

    The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function

  2. Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)

    Time frame: Within one month after surgery

    The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function

  3. Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)

    Time frame: Within three months after surgery

    The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function

  4. Postoperative delirium assessed with the Confusion Assessment Method (CAM)

    Time frame: Up to 7 days after surgery

    The CAM is a validated tool to detect postoperative delirium

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Creatine Intervention in Older Adults to Improve Perioperative Brain Health

Acronym: CREATE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 30, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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