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Search / Trial NCT06480708

Evaluation of the Ketogenic Diet to Improve Post Operative Cognitive Decline in Cardiac Surgery

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Jun 24, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Postoperative Cognitive Decline Ketogenic Diet Ketosis Neuroinflammation Cell Apoptosis 7 T Mri Proton Magnetic Resonance Spectroscopy

ClinConnect Summary

This clinical trial is studying whether a special diet called the ketogenic diet (or KD) can help improve thinking and memory problems that some patients may experience after heart surgery, specifically coronary artery bypass grafting (CABG). These problems, known as postoperative cognitive dysfunction (POCD), can make recovery harder and sometimes lead to long-term issues with memory and brain health. The researchers will compare the effects of the ketogenic diet, which is high in fats and low in carbohydrates, with a regular diet over a period of 14 days before the surgery. They hope that the ketogenic diet will reduce the chances and severity of these cognitive problems after surgery.

To be eligible for this trial, participants must be at least 60 years old and scheduled for elective heart surgery. They should also have a good baseline cognitive score and not show any signs of confusion before the surgery. During the trial, participants will follow their assigned diet and undergo brain imaging to measure key factors related to brain health before and after the diet period. This study is important because it could lead to new ways to help older patients recover better after heart surgery and potentially protect their brain health in the long run.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • 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.
  • Exclusion criteria (general):
  • 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.
  • Exclusion criteria (MRI/MRS):
  • Claustrophobia
  • Patients with any metal in their body.
  • Patients with pacemakers/internal defibrillators/neurostimulators.
  • Patients who have any form of stents.

About University Of Missouri Columbia

The University of Missouri-Columbia is a leading academic institution dedicated to advancing medical research and clinical innovation. As a prominent sponsor of clinical trials, the university leverages its extensive resources and expertise to facilitate groundbreaking studies aimed at improving patient outcomes across a variety of health conditions. With a commitment to ethical research practices and collaboration with multidisciplinary teams, the University of Missouri-Columbia strives to translate scientific discoveries into effective therapeutic interventions, ultimately enhancing the quality of care in the communities it serves.

Locations

Columbia, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Antoinette Burger, PhD

Principal Investigator

Department of Anesthesiology and Perioperative Medicine, University of Missouri-Columbia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported