Creatine and Perioperative Brain Health

NCT07310043 | Not Yet Recruiting DMC

• 1 other identifier: 2025P002111
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neurocognitive Disorders; Postoperative Delirium

Keywords

Perioperative Brain Health; Creatine; Perioperative Neurocognitive Disorders

Outcome Measures

Primary Outcomes (4)

• 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

  Within three weeks before surgery

• 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

  Within one month after surgery

• 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

  Within three months after surgery

• Postoperative delirium assessed with the Confusion Assessment Method (CAM)

  The CAM is a validated tool to detect postoperative delirium

  Up to 7 days after surgery

Study Arms (2)

Creatine group

EXPERIMENTAL

Patients in the creatine group will be instructed to take approximately 20g of creatine monohydrate daily for one week, followed by a maintenance phase of approximately 5g per day

Dietary Supplement: Creatine monohydrate

Placebo group

PLACEBO COMPARATOR

Placebo group patients will be instructed to take a placebo following the same regimen as the creatine group.

Other: Placebo

Interventions

Placebo OTHER

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

Placebo group

Creatine monohydrate DIETARY_SUPPLEMENT

Participants will receive creatine supplementation before surgery

Creatine group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Neurocognitive Disorders; Emergence Delirium

Interventions

Creatine

Condition Hierarchy (Ancestors)

Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07