Evaluation of the Ketogenic Diet to Improve Post Operative Cognitive Decline in Cardiac Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
Postoperative cognitive decline (POCD) is a significant neurological problem that commonly follows coronary artery bypass grafting surgery (CABG) in elderly patients. This can result in longer hospital stays and generate worsening morbidity and mortality. Furthermore, POCD often persists in some patients for more than a year and puts them at higher risk for developing Alzheimer's Disease or dementia. The cause of POCD is a topic of ongoing work, with recent hypotheses linked with cell dysfunction and death in the brain, and neuroinflammation related to the surgical trauma and related systemic inflammation. In this project, the investigators will test whether the pre-operative use (14 days) of a ketogenic diet (KD), compared to a control diet (CD) will lower the incidence, duration, and severity of POCD in cardiac patients. The ketogenic diet has been associated with improved memory function, as well as reduction of inflammation in conditions such as epilepsy, Alzheimer's Disease and Parkinson's Disease. A subset of patients from each group will also undergo a 7 Tesla magnetic resonance imaging and spectroscopy scan, where key brain metabolites of mitochondrial function and neuronal integrity will be measured in the prefrontal cortex and hippocampus. In the KD group, cerebral b-hydroxybutyrate (BHB) to evaluate cerebral ketosis will also be measured. These will be measured prior to starting the KD/CD and after a minimum of 10 days on the KD/CD. From both CD and KD groups, levels of key cytokines linked with inflammation will be measured during the protocol. Our outcome parameters for POCD will include measures that evaluate cognition, delirium and length of hospitalization. The following hypotheses will be investigated: 1) lower incidence, duration and severity of POCD in the KD group, compared to the CD group; and 2) better pre-operative values of neuronal integrity and in the KD group, higher levels of brain ketone levels will be associated with patients who do not experience POCD or have less severe POCD. This project tests the use of the multi-factorial effects of the KD for an important problem in Anesthesiology. With state-of-the-art imaging technology and cytokine evaluation, the investigators hypothesize this work can have substantial implications for prevention and management of postoperative cognitive decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
June 11, 2025
June 1, 2025
11 months
June 15, 2024
June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative cognitive decline (POCD)
POCD will be measured for 3 days postoperatively or until delirium resolves
3 days
Secondary Outcomes (4)
Neuroinflammatory metabolite concentrations in participants on ketogenic diet vs control diet
10-14 days
Effect of ketogenic diet on cerebral ketosis
10-14 days
Peripheral cytokine levels in participants on ketogenic diet vs control diet
16 days
Effect of ketogenic diet on systemic ketosis
16 days
Study Arms (2)
Ketogenic diet group
EXPERIMENTAL20 participants will be randomized to a ketogenic diet group and will consume the ketogenic diet for 14 days prior to undergoing open heart surgery.
Control diet group
ACTIVE COMPARATOR20 participants will be randomized to a control diet group and will consume the control diet for 14 days prior to undergoing open heart surgery.
Interventions
The ketogenic diet consisting of fats (70%), protein (20%) and carbohydrates (10%) will be consumed for 14 days prior to undergoing open-heart surgery, and up to 6 days postoperatively or until discharge (if within 6 days postoperatively).
The control diet consisting of a Mediterranean diet, at 25% fat, 20% protein and 55% carbohydrates will be consumed for 14 days prior to undergoing open-heart surgery, and up to 6 days postoperatively or until discharge (if within 6 days postoperatively).
Eligibility Criteria
You may qualify if:
- Age ≥ 60 years old
- Undergoing elective on-pump coronary artery bypass grafting (CABG) surgery with/without valve repair/replacement.
- Mini-Cog score \>4 at baseline.
- Negative for delirium on the CAM at baseline.
You may not qualify if:
- Pre-existing diagnosis of dementia, Alzheimer's Disease, Parkinson's Disease.
- Emergent CABG ± valve surgery.
- Patients already hospitalized for CABG ± valve surgery.
- Patients using GLP-1 agonists.
- Inability to provide written, informed consent in English.
- Patients who cannot tolerate the KD.
- Patients with alcoholism.
- Patients with liver failure.
- Patients with uremia.
- Mini-Cog score \<4 at baseline.
- Positive for delirium on the CAM at baseline.
- Claustrophobia
- Patients with any metal in their body.
- Patients with pacemakers/internal defibrillators/neurostimulators.
- Patients who have any form of stents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University on Missouri Hospital
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoinette Burger, PhD
Department of Anesthesiology and Perioperative Medicine, University of Missouri-Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 15, 2024
First Posted
June 28, 2024
Study Start
January 15, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
June 11, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
We will conform to institutional (University of Missouri) and NIH data and resource sharing policies. New methods, data, and insights that arise from the work conducted will be available to benefit the scientific community and the public according to these guidelines, which include: i) timely publication of results from project findings; ii) presentation of results at local/national/ international meetings/symposia; iii) deposition of certain large data-sets into public repositories; iv) project compliance with any Freedom of Information Act requests. Should any intellectual property arise which requires a patent, the investigators will ensure that the technology (materials and data) remains widely available to the research community in accordance with University policies and the NIH Principles and Guidelines document.