Creatine and Perioperative Brain Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients scheduled for elective surgery under general anesthesia
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Creatine monohydrate
Dietary supplementParticipants will receive creatine supplementation before surgery
Placebo
Other interventionParticipants in the placebo group will receive an identical placebo before surgery
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Creatine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Preoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)
The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function
Time frame
Within three weeks before surgery2
Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)
The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function
Time frame
Within one month after surgery3
Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)
The MoCA is a validated tool to assess cognitive function. Scores range from 0-30, with higher scores representing better cognitive function
Time frame
Within three months after surgery4
Postoperative delirium assessed with the Confusion Assessment Method (CAM)
The CAM is a validated tool to detect postoperative delirium
Time frame
Up to 7 days after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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