Creatine Intervention in Older Adults to Improve Perioperative Brain Health
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Primary Endpoint
- Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA)
Overview
Brief Summary
The goal of this study is to understand the effects of oral creatine supplementation in the perioperative period. Creatine is commonly used to enhance athletic performance, but it can also have positive effects on the brain. Since surgery can lead to alterations in thinking, memory, and attention patterns in some patients, we will assess whether creatine can be protective against these changes in older adults undergoing surgery.
Detailed Description
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 and are among the most common surgical complications in aging populations. Beyond their considerable economic burden, estimated to exceed $30 billion annually, PND impose 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 demonstrated neuroprotective effects in other high-stress conditions. However, its potential to mitigate perioperative cognitive vulnerability has not been previously investigated. This study will evaluate creatine supplementation as a novel protective strategy to reduce the risk of PND in older adults undergoing surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients scheduled for elective surgery under general anesthesia
Exclusion Criteria
- •History of creatine deficiency disorders
- •Severe neurologic or psychiatric diseases
- •History of stroke or head trauma
- •Obesity (BMI ≥ 30 kg.m-²), kidney or liver disease
Arms & Interventions
Patients under creatine monohydrate intervention
Intervention: Creatine monohydrate (Dietary Supplement)
Outcomes
Primary Outcomes
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
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
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
Postoperative delirium assessed with the Confusion Assessment Method
Time Frame: Up to 7 days after surgery
The CAM is a validated tool to detect postoperative delirium
Secondary Outcomes
No secondary outcomes reported
Investigators
Susana Vacas, MD, PhD
Associate Professor
Massachusetts General Hospital