124 Participants NeededMy employer runs this trial

Ketogenic Diet for Fatty Liver

AS
CE
Overseen ByCrystal Engelage, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a ketogenic diet (a low-carb diet) can benefit people with non-alcoholic fatty liver disease who require liver surgery. The study compares two groups: one follows a ketogenic diet for four weeks before surgery, while the other adheres to a typical diet advised by Canada's Food Guide. The researchers aim to determine if the ketogenic diet improves surgery outcomes and reduces liver fat. The trial seeks participants with non-alcoholic fatty liver disease who are preparing for liver surgery and can track their food intake using an app.

As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on liver surgery outcomes.

Is there any evidence suggesting that the ketogenic diet is safe for patients undergoing liver surgery?

Research has shown that most people tolerate the ketogenic diet well. This diet, high in fats and low in carbohydrates, helps the body use fat for energy instead of sugar. Studies have found that it aids in weight loss and improves cholesterol and blood sugar levels.

Regarding safety, some individuals might experience fatigue or headaches, especially at the start. These side effects are usually temporary and often subside as the body adjusts to the diet. Following the diet as advised and maintaining communication with healthcare providers is important to address any concerns.

The ketogenic diet is already used in medicine, primarily to treat epilepsy in children, indicating its safety when managed properly. Most people who try a keto diet do not encounter serious issues. However, like any significant dietary change, consulting a doctor or dietitian ensures it aligns with individual health needs.12345

Why are researchers excited about this trial?

The ketogenic diet is unique because it shifts the body's metabolism from using carbohydrates as a primary energy source to burning fats, which may help reduce liver fat more effectively. Unlike the standard of care for fatty liver, which typically focuses on balanced diets as per guidelines like Canada's Food Guide, the ketogenic diet emphasizes high fat, moderate protein, and very low carbohydrate intake. Researchers are excited about this approach because it targets the root metabolic processes, potentially offering quicker and more substantial improvements in liver health compared to traditional dietary recommendations.

What evidence suggests that a ketogenic diet might be an effective treatment for fatty liver?

Research has shown that a ketogenic diet can help reduce liver fat in people with non-alcoholic fatty liver disease (NAFLD). One study found that this diet led to significant weight loss and improved liver health. Another study demonstrated that a ketogenic diet lowered liver fat, a key goal in treating NAFLD, and improved liver function by balancing energy use. In this trial, participants in the Ketogenic Diet Arm will follow a well-formulated ketogenic diet for 4 weeks. Overall, these findings suggest that the ketogenic diet could be a promising way to reduce liver fat and enhance liver health in those with NAFLD.678910

Who Is on the Research Team?

AS

Anton Skaro, MD PhD

Principal Investigator

London Health Sciences Centre/Lawson Health Research Institute

Are You a Good Fit for This Trial?

This trial is for people who have fatty liver (seen on a scan or biopsy) and are scheduled for liver surgery. Participants must be able to use an app to track their food intake.

Inclusion Criteria

I am 18 or older and having liver surgery for colorectal cancer that has spread to my liver.
I have fatty liver seen on imaging or biopsy.
Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention

Exclusion Criteria

I do not have fatty liver disease.
I have signs of liver fibrosis or cirrhosis on my tests or scans.
I have liver fat buildup caused by alcohol use.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Diet

Participants follow a 4-week preoperative diet, either a ketogenic diet or a standard of care diet, with dietary consultation and tracking via the Cronometer app

4 weeks
Weekly virtual check-ins

Surgery

Participants undergo liver surgery to remove tumors, with intraoperative monitoring of blood loss and operative time

Operative period

Immediate Postoperative Monitoring

Participants are monitored for perioperative blood transfusion and immediate postoperative complications

7 days

Follow-up

Participants are monitored for postoperative complications, liver failure, and hospital readmission within 30 days of surgery

30 days

Long-term Follow-up

Participants are monitored for disease recurrence, cancer-related mortality, and measurement of circulating cell-free tumor DNA up to 5 years postoperatively

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet

Trial Overview

The study compares a short-term (4 week) ketogenic diet, which is very low in carbs, with standard pre-surgery dietary advice to see if it reduces liver fat and improves surgery outcomes. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic Diet ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anton Skaro

Lead Sponsor

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Citations

Beneficial effects of the ketogenic diet on nonalcoholic fatty ...

Beneficial effects of the ketogenic diet on nonalcoholic fatty liver disease: A comprehensive review of the literature ... liver fat content ...

Ketogenic Diet in Steatotic Liver Disease: A Metabolic ...

It encompasses a spectrum of hepatic disorders characterized by hepatic steatosis once secondary causes of fat accumulation, such as excessive alcohol intake, ...

Effect of a ketogenic diet on nonalcoholic fatty liver disease ...

Effect of a ketogenic diet on nonalcoholic fatty liver disease (NAFLD) ... The primary outcome was reduction of hepatic steatosis as measured by ...

Ketogenic diet time-dependently prevents NAFLD through ...

Our data ... Lehtimäki, et al. Effect of a ketogenic diet on hepatic steatosis and hepatic mitochondrial metabolism in nonalcoholic fatty liver disease.

Ketogenic Diet in Non-alcoholic Fatty Liver Disease

The purpose of this randomized trial is to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD).

The Ketogenic Diet: A Detailed Beginner's Guide to Keto

The ketogenic diet involves consuming a very low amount of carbohydrates and replacing them with fat to help your body burn fat for energy.

Diet Review: Ketogenic Diet for Weight Loss

A ketogenic diet has been shown to provide short-term benefits in some people including weight loss and improvements in total cholesterol, blood sugar, and ...

Ketogenic diet

The ketogenic diet is a high-fat, adequate-protein, low-carbohydrate dietary therapy that in conventional medicine is used mainly to treat hard-to-control ( ...

A Review of Ketogenic Diet and Lifestyle - PMC - NIH

The classic ketogenic diet is defined as a diet with one gram protein per kilogram of body weight, 10–15g carbohydrates per day, and the remaining calories ...

Ketogenic Diet

A ketogenic diet (keto) is a specialized diet used to treat a number of conditions, including epilepsy. Learn more from Boston Children's Hospital.