Ketogenic Diet for Cognitive Impairment After Surgery

Overseen By Paige A Spencer, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: GLP-1 agonists

Disqualifiers: Dementia, Alzheimer's, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketogenic diet (high fat, low carb) can reduce memory and thinking problems after heart surgery. Patients will follow either this diet or a regular diet for two weeks before surgery to assess its impact on mental recovery. It targets individuals over 60 scheduled for specific heart surgeries, without existing memory-related diseases. The study aims to determine if the ketogenic diet can lower the risk of cognitive issues post-surgery. As an unphased trial, it provides a unique opportunity to contribute to understanding dietary impacts on cognitive recovery after surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using GLP-1 agonists, you cannot participate in the trial.

Is there any evidence suggesting that the ketogenic diet is safe for humans?

Research has shown that a ketogenic diet, high in fats and low in carbohydrates, can improve memory in older adults with mild memory problems. This finding suggests it might also aid memory issues after surgery. Other studies have examined the safety of ketogenic diets and found them generally safe and well-tolerated, even in serious conditions like brain cancer when combined with standard treatments.

Participants in these studies did not experience significant negative side effects from following a ketogenic diet, indicating its likely safety for surgical patients.

While the ketogenic diet appears promising, individual experiences can vary. It is important to consult a doctor with any concerns or questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ketogenic diet for cognitive impairment after surgery because it offers a unique approach compared to traditional treatments, which often include medications targeting specific neurotransmitters. The ketogenic diet shifts the body's energy source from carbohydrates to fats, producing ketones that may have neuroprotective effects and improve brain function. This dietary approach is non-invasive and could potentially show benefits in a shorter timeframe, offering a promising alternative for enhancing cognitive recovery after surgery.

What evidence suggests that the ketogenic diet might be an effective treatment for cognitive impairment after surgery?

Research has shown that a ketogenic diet can improve memory in older adults with mild memory problems. This diet, high in fats and low in carbohydrates, helps the brain use ketones for energy instead of glucose. Ketones, a type of fuel, may protect brain cells and reduce inflammation. Some studies suggest that the ketogenic diet may also help with diseases like Alzheimer's, which is linked to memory issues. In this trial, participants will be randomized to either a ketogenic diet group or a control diet group to evaluate the ketogenic diet's potential to reduce memory loss after surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Antoinette Burger, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Negative for delirium on the CAM at baseline

I am 60 years old or older.

I am scheduled for heart bypass surgery that may include valve repair or replacement.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Diet Intervention

Participants follow either a ketogenic diet or control diet for 14 days prior to surgery

2 weeks

Dietary monitoring and compliance checks

Surgery and Immediate Postoperative Monitoring

Participants undergo open heart surgery and are monitored for postoperative cognitive decline

3 days

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive assessments and imaging

2 weeks

Follow-up visits for cognitive assessments and imaging

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Ketogenic diet group Experimental Treatment 1 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 group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A clinical decision support alert significantly reduced the prescription of carbohydrate-containing medications in hospitalized children on a ketogenic diet, decreasing orders from 0.69 to 0.35 per patient-day, which prevented 256 inappropriate orders.

The alert was accepted 57% of the time when it fired, demonstrating that user-centered design can effectively influence prescriber behavior and enhance patient safety without overwhelming healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Prescribing Errors in Hospitalized Children on the Ketogenic Diet. Siegel, BI., Johnson, M., Dawson, TE., et al.[2021]

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

A 4-year-old girl with a rare FBXL4 gene mutation and severe lactic acidosis was successfully treated with a ketogenic diet (KD) after standard treatments failed, highlighting the KD's potential in managing mitochondrial disorders.

This case represents the first documented use of parenteral KD to effectively reduce lactic acidosis in a patient with mitochondrial depletion syndrome, suggesting a promising nonpharmacological intervention for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. İnci, A., Aktaş, E., Cengiz Ergin, FB., et al.[2022]

A new ketogenic diet (KD) designed for adults significantly improved recovery from traumatic brain injury (TBI) in mice, showing reduced sensorimotor deficits and improved spatial memory over a 70-day study period.

The new-KD increased levels of Beta-hydroxybutyrate (β-HB) and enhanced the mTOR pathway, leading to reduced inflammation and tissue damage, suggesting it has therapeutic potential for treating TBI in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new ketogenic formulation improves functional outcome and reduces tissue loss following traumatic brain injury in adult mice. Thau-Zuchman, O., Svendsen, L., Dyall, SC., et al.[2021]

In a mouse model of malignant glioma, a ketogenic diet (KetoCal®) significantly increased survival by approximately 5 days compared to a standard diet, indicating its potential as a supportive treatment in cancer therapy.

The combination of the ketogenic diet and radiation therapy showed more than additive effects, with tumor growth significantly reduced in most mice on the ketogenic diet, suggesting that metabolic changes from the diet could enhance the effectiveness of conventional cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. Abdelwahab, MG., Fenton, KE., Preul, MC., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06480708

Evaluation of the Ketogenic Diet to Improve Post Operative ... 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 ...

2. withpower.com withpower.com/trial/phase-cognitive-dysfunction-4-2025-af25b

Ketogenic Diet for Cognitive Impairment After Surgery Research shows that a ketogenic diet, which is high in fats and low in carbohydrates, can improve memory in older adults with mild cognitive impairment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11767209/

Impact of the Ketogenic Diet on Neurological Diseases The results demonstrated significant reductions in body mass index (BMI), waist circumference, fat mass, and resting metabolic rate following the intervention.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fsn3.70516

Role of Dietary Carbohydrates in Cognitive Function: A ... Ketogenic diet and carbohydrate restriction, Low-carbohydrate, high-fat diets reduce glucose reliance and promote ketone usage, Improves ...

5. nature.com nature.com/articles/s41392-021-00831-w

Ketogenic diet for human diseases: the underlying ... The ketogenic diet (KD) is a high-fat, adequate-protein, and very-low-carbohydrate diet regimen that mimics the metabolism of the fasting state to induce the ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK209323/

Ketogenic Diet - Nutrition and Traumatic Brain Injury - NCBI A combined analysis of outcome data from eleven cohort studies published ... Based on the evidence presented, the ketogenic diet does hold some promise of ...

7. nature.com nature.com/articles/s41598-025-06675-6

A phase 1 safety and feasibility trial of a ketogenic diet plus ... This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded ...