Ketone Esters for Fatty Liver Disease

(JV Trial)

This trial aims to determine if a daily ketone ester drink can improve liver health and blood sugar control in individuals with fatty liver disease. Participants will be randomly assigned to consume either the ketone ester (bis-octanoyl (R)-1,3-butanediol, also known as C8 ketone di-ester) or a placebo for six weeks. The trial seeks individuals with a BMI over 30 who have been diagnosed with fatty liver disease and do not have other complicating conditions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

You may need to stop taking certain medications that affect the study outcomes, like corticosteroids, but you can continue taking metformin if you've been on a stable dose for at least 3 months without any stomach issues. The trial protocol doesn't specify other medications, so it's best to discuss your current medications with the study team.

Research has shown that daily consumption of a C8 ketone di-ester, a type of ketone drink, is generally safe and well-tolerated by healthy older adults. In one study, participants who consumed this ketone drink reported no serious side effects, suggesting its safety for use. However, individual responses can vary, so monitoring for any negative effects during the trial is important.¹²³⁴⁵

Unlike the standard treatments for fatty liver disease, which often involve lifestyle changes and medications like vitamin E or pioglitazone, the C8 ketone di-ester offers a novel approach. This treatment is unique because it introduces a new active ingredient, bis-octanoyl (R)-1,3-butanediol, which is a ketone ester. Ketone esters can provide an alternative energy source for the liver, potentially reducing liver fat more effectively. Researchers are excited because this treatment targets the condition in a totally different way, offering hope for quicker and possibly more profound improvements.

Research has shown that ketone esters, such as bis-octanoyl (R)-1,3-butanediol, might help reduce liver fat and improve liver health. The liver naturally produces ketones when the body burns fat, especially during fasting or low-carb diets. One study found that this ketone ester raised ketone levels in the body, potentially decreasing liver fat. Another study discovered that ketone esters could improve nonalcoholic fatty liver disease by reducing liver fat and enhancing liver function. In this trial, participants will receive either the C8 ketone di-ester or a placebo to evaluate its potential benefits in treating fatty liver disease.¹²⁴⁶⁷