About this trial
MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer.
It is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is known that our diet plays a role. Research shows a diet high in a type of sugar called fructose might make MASLD worse. Fructose is found in fruit, honey and table sugar, and lots of processed food and drinks. The body deals with fructose differently to other sugars, which is why fructose may be a problem. Although scientists have studied the effects of fructose in healthy people, no studies so far have included people with MASH, so it is not known if fructose might make the condition worse.
To answer this question, the researchers will conduct a four-week randomised, double-blind study to compare the effects of fructose with another sugar called glucose in 36 people with MASH, 18 people with 'simple' MASLD, and 18 controls without liver disease. Participants will follow a low-sugar diet and, after 14 days on this diet, they will add either a glucose or fructose supplement for another 14 days. Participants will attend 3 study visits, where blood, urine, stool, and saliva samples will be taken. The main question is whether fructose causes more inflammation in people with MASH compared to those with MASLD, or people without liver disease. The researchers will also investigate how fructose affects liver fat content, the gut microbiota, and other processes relevant to MASLD/MASH.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able and willing to give written informed consent
Age 45-65 at consent
HbA1c < 48 mmol/mol
23.0kg/m2 - 32.4kg/m2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations
Disqualifiers
Unwilling or unable to give consent
Age <45 or >65
Any form of diabetes mellitus
Currently pregnant
Trial design
Parallel
Treatments tested in this trial
fructose
Dietary supplementFructose powder
glucose
Dietary supplementGlucose powder
Treatment groups
Trial outcomes
Primary outcomes
Change in plasma glutamate concentration
Difference in the fructose-induced changes in plasma glutamate concentration in patients with MASH and fibrosis compared to patients with simple steatosis (without fibrosis) or healthy controls.
Secondary outcomes
Plasma metabolome
Changes in plasma metabolome from blood samples measured by mass spectrometry
Urine metabolome
Changes in urine metabolome measured by mass spectrometry
Plasma glucose
Changes in fasting and post-prandial plasma glucose (mmol/L)
Plasma triglycerides
Change in fasting and post-prandial plasma triglycerides (mmol/L)
Other outcomes
Genetic variants
Measures of genetic variants relevant to MASLD/MASH and/or relevant metabolic processes, including sugar digestion/metabolism, inflammation, and/or liver metabolism.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
King's College London
Collaborator
University of Surrey
Collaborator