Neurocognitive DisordersCREATENCT07310043
Creatine and Perioperative Brain Health
A study testing Creatine monohydrate in people with Neurocognitive Disorders and Postoperative Delirium, run by Massachusetts General Hospital.
Trial summary
The overall goal of this study is to explore the effects of perioperative oral creatine supplementation 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders, Postoperative Delirium, Postoperative Outcomes
- What is being tested?
- Creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-85 years, inclusive.
- Undergoing elective orthopedic surgery.
Who cannot join
- History of creatine deficiency disorders
- Renal or neurodegenerative disorders
- Poorly controlled diabetes mellitus
- History of stroke or significant head trauma, presence of intracranial mass lesions
- Alcohol or substance abuse
- Patients taking entecavir or pemetrexed
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- Prior creatine use within four weeks of enrollment
- Allergy to any component of the intervention or placebo
- Inability to give informed consent.
About this study
Official title: Creatine Intervention in Older Adults to Improve Perioperative Brain Health: a Randomized Controlled Trial (CREATE Trial)
The overall goal of this study is to explore the effects of perioperative oral creatine supplementation 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.
- Being tested
- Creatine monohydrate, Placebo
- Keywords
- Perioperative Brain Health, Creatine, Perioperative Neurocognitive Disorders, Postoperative Outcomes
- Medical subject headings
- Neurocognitive Disorders, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
Creatine monohydrate gummies
PlaceboOther
Placebo gummies
| Study group | Role | What they receive |
|---|---|---|
| Creatine group | Experimental | Participants will be instructed to take 20g of creatine monohydrate (in gummy form) daily for 1 week, followed by a maintenance phase of 5g per day for the next 2 weeks leading up to surgery. Receives: Dietary Supplement: Creatine monohydrate |
| Placebo group | Placebo comparator | Placebo group participants will be instructed to take placebo gummies following the same regimen. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Neurocognitive Disorders (PND)
Composite endpoint that includes patients with any decrease in the telephonic Montreal Cognitive Assessment or NIH Mobile Toolbox® scores between baseline and 1 month postoperatively, between baseline and 6 months postoperatively or between baseline and 12 months postoperatively.
Measured: 1 month, 6 months and 12 months after surgery
Secondary outcomes (13)
Postoperative delirium (POD)
Will be assessed with the 3D Confusion Assessment Method twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.
Measured: First seven days postoperatively or until hospital discharge, whichever came first, up to seven days
Hospital Length of Stay
It will be defined as the number of days after surgery until the time of discharge from the hospital.
Measured: Postoperatively until discharge, an average of two days
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Patients will self-administer PROMIS measures that will include the Global Health Short Form (SF), Physical Function SF, Cognitive Function Abilities SF, Pain Interference SF, and Sleep Disturbances SF. PROMIS measures will be administered at baseline and at 1 and 6 months postoperatively. Scores will be converted to T-scores with a mean of 50 and a standard deviation of 10.
Measured: 1 month and 6 months after surgery
Pain Scores
Will be assessed via nursing documentation. Pain will be evaluated as pain at 24 hours postoperatively and as the worst pain within 72 hours postoperatively. In addition, we will evaluate a trajectory of pain scores over the first 72 hours postoperatively.
Measured: From the immediate postoperative period up to 72 hours after surgery
Discharge Disposition
Will be assessed as the patient's destination upon hospital discharge. This will be analyzed as home versus non-home discharge.
Measured: At hospital discharge, an average of two days after surgery
Morbidity
This will be evaluated as a composite outcome of events, including reintubation, reintervention, cardiopulmonary arrest, myocardial infarction, sepsis/septic shock, stroke, pulmonary embolism, deep vein thrombosis, acute renal failure requiring hemodialysis, urinary tract infection, pneumonia, infection of surgical wound, other infection, and dehiscence of the surgical wound. These outcomes will be assessed using a medical record review.
Measured: Postoperatively until discharge, an average of two days after surgery, and at 30 days postoperatively
Mortality
Will be assessed using a combination of electronic medical record review and family report during follow-up.
Measured: Postoperatively until discharge, an average of two days after surgery, and at 30 days postoperatively
Step count (Wearable Device Metrics)
Daily step count (steps per day) will be collected from wearable devices as a repeated measure.
Measured: From baseline up to 12 months postoperatively
Metabolic equivalent of task (Wearable Device Metrics)
Daily average metabolic equivalent of task data will be collected from wearable devices as a repeated measure.
Measured: From baseline up to 12 months postoperatively
Heart rate variability (Wearable Device Metrics)
Heart rate variability (milliseconds) will be collected from wearable devices as a repeated measure.
Measured: From baseline up to 12 months postoperatively
Resting heart rate (Wearable Device Metrics)
Resting heart rate (beats per minute) will be collected from wearable devices as a repeated measure.
Measured: From baseline up to 12 months postoperatively
Temperature (Wearable Device Metrics)
Skin temperature measurements (°C) will be collected from wearable devices as a repeated measure.
Measured: From baseline up to 12 months postoperatively
Sleep Stages (Wearable Device Metrics)
Sleep stages will be assessed using wearable device data, including the duration of time spent in light sleep, deep sleep, and rapid eye movement sleep (minutes), collected as repeated measures.
Measured: From baseline up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Vacas, MD, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310043
- Sponsor's protocol ID
- 2026P000870
- Acronym
- CREATE
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Intervention in Older Adults to Improve Perioperative Brain Health: a Randomized Controlled Trial (CREATE Trial)
- ClinicalTrials.gov ID
- NCT07310043
- Acronym / sponsor ID
- CREATE / 2026P000870
- Keywords
- Perioperative Brain Health, Creatine, Perioperative Neurocognitive Disorders, Postoperative Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to explore the effects of perioperative oral creatine supplementation 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine group | Experimental | Dietary Supplement: Creatine monohydrateParticipants will be instructed to take 20g of creatine monohydrate (in gummy form) daily for 1 week, followed by a maintenance phase of 5g per day for the next 2 weeks leading up to surgery. |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo group participants will be instructed to take placebo gummies following the same regimen. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 60-85 years, inclusive.
- Undergoing elective orthopedic surgery.
Key exclusion criteria (9 listed)
- History of creatine deficiency disorders
- Renal or neurodegenerative disorders
- Poorly controlled diabetes mellitus
- History of stroke or significant head trauma, presence of intracranial mass lesions
- Alcohol or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine monohydrateCreatine monohydrate gummies | Dietary supplement | Creatine group |
| PlaceboPlacebo gummies | Other | Placebo group |
Primary outcome
Perioperative Neurocognitive Disorders (PND)
Time frame: 1 month, 6 months and 12 months after surgery
Composite endpoint that includes patients with any decrease in the telephonic Montreal Cognitive Assessment or NIH Mobile Toolbox® scores between baseline and 1 month postoperatively, between baseline and 6 months postoperatively or between baseline and 12 months postoperatively.
13 secondary outcomes
Postoperative delirium (POD)
Time frame: First seven days postoperatively or until hospital discharge, whichever came first, up to seven days
Hospital Length of Stay
Time frame: Postoperatively until discharge, an average of two days
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Time frame: 1 month and 6 months after surgery
Pain Scores
Time frame: From the immediate postoperative period up to 72 hours after surgery
Discharge Disposition
Time frame: At hospital discharge, an average of two days after surgery
Morbidity
Time frame: Postoperatively until discharge, an average of two days after surgery, and at 30 days postoperatively
Mortality
Time frame: Postoperatively until discharge, an average of two days after surgery, and at 30 days postoperatively
Step count (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Metabolic equivalent of task (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Heart rate variability (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Resting heart rate (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Temperature (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Sleep Stages (Wearable Device Metrics)
Time frame: From baseline up to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Neurocognitive Disorders and Postoperative Delirium, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Neurocognitive Disorders (PND) (time frame: 1 month, 6 months and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.