Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for elderly patients undergoing coronary artery bypass grafting surgery who may be at risk of postoperative cognitive decline (POCD). Participants must be willing to follow a special diet before their surgery. Details on specific inclusion and exclusion criteria are not provided.Inclusion Criteria
I am 60 years old or older.
I am scheduled for heart bypass surgery that may include valve repair or replacement.
My memory and thinking ability test score is above 4.
Exclusion Criteria
I have been diagnosed with dementia, Alzheimer's, or Parkinson's.
I need or have had urgent coronary artery bypass graft surgery, with or without valve surgery.
I am in the hospital for bypass or valve surgery.
I am currently taking GLP-1 agonist medication.
I have liver failure.
I have uremia.
My memory and thinking test score is below 4.
Treatment Details
The study compares the effects of a ketogenic diet (KD) versus a control diet (CD) on POCD in cardiac patients. It involves pre-operative use of these diets for 14 days and includes advanced brain imaging and inflammation marker tests.
2Treatment groups
Experimental Treatment
Active Control
Group I: Ketogenic diet groupExperimental Treatment1 Intervention
20 participants will be randomized to a ketogenic diet group and will consume the ketogenic diet for 14 days prior to undergoing open heart surgery.
Group II: Control diet groupActive Control1 Intervention
20 participants will be randomized to a control diet group and will consume the control diet for 14 days prior to undergoing open heart surgery.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University on Missouri HospitalColumbia, MO
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
National Institutes of Health (NIH)Collaborator