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RecruitingNAINTERVENTIONAL

Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis

This study is investigating if a special low-carbohydrate diet, called a ketogenic diet, can reduce fat in the liver before surgery. Many people, especially with rising obesity rates, have non-alcoholic fatty liver disease (NAFLD). If you have fatty liver, it can sometimes increase the chance of bleeding during liver surgery or cause complications afterwards. Researchers want to see if following a ketogenic diet for four weeks before surgery helps improve outcomes like reducing blood loss and speeding up recovery. Half of the patients will follow this diet, and the other half will receive standard dietary advice. This study aims to provide clear answers on whether this diet can make liver surgery safer for those who need it.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Anton Skaro
Enrolment target
124
Start
01 May 2024
Estimated completion
01 Dec 2032

What is this study about?

Imagine your liver has too much fat, a condition called fatty liver disease. This is becoming quite common, not just in Canada but around the world. If you need liver surgery, having fatty liver can sometimes make the surgery more complicated. For example, it might lead to more bleeding during the operation or a higher chance of issues afterwards.

Researchers are investigating whether a special diet, known as a ketogenic diet, could help. This diet is very low in carbohydrates (sugars and starches) and has been shown to reduce fat in the liver quite effectively, even over a short period. The idea is that by reducing liver fat before surgery, patients might have a smoother experience with fewer problems.

This study will compare two groups of patients. One group will follow the special ketogenic diet for four weeks before their liver surgery. The other group will receive standard dietary advice, similar to what's recommended in general healthy eating guidelines. By doing this, the researchers hope to understand if the ketogenic diet truly makes a difference in terms of how much blood is lost during surgery, how quickly people recover, and their overall health outcomes after the operation.

Key takeaways

  • This study evaluates a low-carb diet before liver surgery.
  • Aims to reduce liver fat and improve surgery outcomes.
  • Compares a ketogenic diet to standard dietary advice.
  • Participation involves tracking food intake via an app.
  • Focuses on patients with fatty liver needing surgery for bowel cancer spread.

Who may be eligible?

To join this study, you need to be at least 18 years old and preparing to have liver surgery because of bowel cancer that has spread to your liver. It's important that your scans (like CT or MRI) or a liver biopsy show that you have fatty liver.

You also need to be comfortable using a smartphone or tablet app to track what you eat throughout the diet period. This helps the researchers understand how well you’re following the diet.

However, you can't join if you're having liver surgery for other health problems, or if you're taking specific diabetes medications called SGLT-2 inhibitors, as these don't mix well with a ketogenic diet. You also can't participate if you don't have fatty liver, or if you have more serious liver problems like scarring (fibrosis or cirrhosis), fatty liver caused by alcohol, or a known bleeding disorder.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you having liver surgery due to bowel cancer spread?
  3. Have your doctors told you that you have fatty liver?
  4. Are you able to use a smartphone app to record your meals?
  5. Do you NOT have serious liver scarring (fibrosis/cirrhosis)?
  6. Are you NOT taking SGLT-2 inhibitor medications?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two groups by chance. One group will follow a special low-carbohydrate (ketogenic) diet for four weeks before your liver surgery. The other group will receive standard healthy eating advice before surgery. Both groups will meet with a dietitian.

Throughout the four weeks before surgery, you will use an app called Cronometer on your phone or tablet to record everything you eat and drink each day. You'll also send weekly reports from the app to the study team. Researchers will then check things like how much blood you lose during surgery, your recovery after the operation, and your overall health over time.

Potential risks and benefits

Participating in this study might offer a potential benefit if the ketogenic diet helps reduce liver fat, possibly leading to fewer complications during and after your liver surgery. However, there's also a chance the diet might not have a noticeable effect, or you might experience some common side effects associated with starting a ketogenic diet, such as fatigue or digestive changes, which will be discussed with you by the dietitian. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • London Health Sciences Centre/Western University
    Verified postcode
    London, Canada· Recruiting

Common questions

What is a ketogenic diet?

It's a special diet that is very low in carbohydrates (like bread, pasta, sugar), moderate in protein, and high in healthy fats. This diet encourages your body to burn fat for energy.

Why is fatty liver a concern for surgery?

When there's too much fat in the liver, it can sometimes make liver surgery more difficult, potentially leading to more bleeding or a higher chance of complications after the operation.

How long does the diet last?

If you're in the diet group, you'll follow the special ketogenic diet for four weeks right before your scheduled liver surgery.

Will I have support for the diet?

Yes, if you're in the diet group, you'll meet with a dietitian who will guide you on how to follow the ketogenic diet safely and effectively.

Do I have to use an app?

Yes, all participants in the study will need to use a specific app to track their daily food and drink intake. This helps the study team monitor your diet.

How to find out more

Anton Skaro, MD PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Preoperative Ketogenic Diet for Reduction of Hepatic Steatos…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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