RecruitingNAINTERVENTIONAL

Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)

This study aims to understand if fructose, a type of sugar found in many foods, can make a liver condition called MASH (Metabolic Dysfunction-Associated Steatohepatitis) worse. MASH is a serious type of fatty liver disease where the liver becomes inflamed and damaged. Researchers want to see if fructose influences inflammation, liver fat, or gut health in people with MASH, compared to those with less severe fatty liver (MASLD) or healthy individuals. Participants will follow a low-sugar diet, then add either a fructose or glucose supplement for two weeks. This four-week study will involve a few visits where blood, urine, stool, and saliva samples will be collected to help scientists understand the link between diet and liver health.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

30 Jun 2025

Estimated completion

01 Apr 2026

MASH - Metabolic Dysfunction-Associated Steatohepatitis MASH With Fibrosis Steatosis of Liver

What is this study about?

MASLD, or Metabolic Dysfunction-Associated Steatotic Liver Disease, is a common condition where too much fat builds up in the liver. For some people, this fat can lead to inflammation and damage, a more serious condition called MASH. Understanding why some people develop MASH and others don't is crucial, as MASH can increase the risk of advanced liver scarring (cirrhosis) and even liver cancer.

While our diet is known to play a part, the exact role of different foods isn't fully clear. This study focuses on fructose, a type of sugar found in fruits, honey, table sugar, and many processed foods. The researchers believe that fructose might affect the body differently from other sugars and could potentially worsen MASLD. Although we know a lot about how fructose affects healthy people, its impact on those already living with MASH hasn't been properly studied.

This research aims to fill that gap. By comparing the effects of fructose with another sugar called glucose, scientists hope to learn if fructose contributes to liver inflammation and other problems in people with MASH. This knowledge could help in developing better advice and treatments for people with these liver conditions, improving their long-term health.

Key takeaways

This study investigates if fructose sugar worsens MASH liver disease.
Compares fructose to glucose in people with MASH, MASLD, and healthy volunteers.
Involves a 4-week dietary intervention with sugar supplements.
Requires three long study visits for tests (blood, urine, stool, saliva).
Aims to understand diet's role in liver inflammation and fat.
Your general medical care will not be affected by participating.

Who may be eligible?

This study is looking for volunteers aged between 45 and 65 years old. To take part, you should not have diabetes and your weight needs to be within a certain range (overweight or moderately obese) for your background. Importantly, you must be able to understand the study and agree to participate in writing.

The study needs three main groups of people: those with MASH (diagnosed with inflammation and some scarring in the liver), those with MASLD (fatty liver without significant inflammation or scarring), and healthy volunteers who do not have liver disease. Doctors will use specific tests, like a liver biopsy or Fibroscan, to figure out which group you fit into.

There are also some reasons why you might not be able to join. For example, if you have cirrhosis (advanced liver scarring), certain other liver diseases, a known allergy to fructose, or if you regularly drink more than a moderate amount of alcohol. You also can't take part if you've recently used certain medications like antibiotics, oral steroids, or treatments for obesity. Smoking or using nicotine products in the last month would also exclude you.

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.

Are you between 45 and 65 years old?
Do you have MASH, MASLD, or are you generally healthy?
Do you not have diabetes?
Are you able to agree to take part in writing?
Do you not have advanced liver scarring (cirrhosis) or other serious liver conditions?
Do you drink less than 14 units of alcohol a week (women) or 21 units (men)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for about four weeks. Before starting, you'll have an initial visit to discuss the study and make sure you're suitable to join. During the study, you'll need to attend three main visits, each lasting around 8 hours. At these visits, you'll have a test meal, and nurses will take hourly blood samples using a small tube placed in your arm. You'll also provide samples of your urine, stool, and saliva.

For the first two weeks of the study, everyone will follow a low-sugar diet. Then, for the next two weeks, you'll add a supplement to your diet: either fructose or glucose. This will be given to you, and neither you nor the study team will know which one you're taking until the end of the study. Your regular medical care for MASH or MASLD will continue as usual, and any important health findings from the study will be shared with your GP or care team.

There's also an optional extra part of the study for a smaller number of people. If you choose to join this, it involves the same visits and tests, but with an extra step involving a small amount of special sugar added to your test meal. You'll also provide breath samples to help researchers understand how your body processes sugar.

Potential risks and benefits

By taking part in this study, you could help researchers better understand how diet, especially fructose, affects MASH and MASLD. This knowledge is vital for developing better ways to manage and treat these liver conditions, potentially benefiting many people in the future. While the direct benefits to you personally might be limited, you'll receive careful monitoring during the study period. Potential risks are generally low, mainly related to the hourly blood draws at study visits, which might cause minor bruising or discomfort. You might also find the low-sugar diet challenging to follow. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting
Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is MASH?

MASH is a serious liver condition where fat builds up and causes inflammation and damage, which can lead to scarring.

What is fructose?

Fructose is a type of sugar found in fruits, honey, table sugar, and many processed foods and drinks.

Will I know if I'm getting fructose or glucose?

No, this is a 'double-blind' study, meaning neither you nor the researchers will know which sugar supplement you're taking until the study ends.

How long will I need to be in the study?

The main part of the study lasts for about four weeks, plus initial screening visits.

What kind of commitment is needed?

You'll have three long visits (around 8 hours each) where blood and other samples are taken, and you'll need to follow a specific diet and take supplements for two weeks each.

How to find out more

William Alazawi, MA(Cantab), MB, PhD

w.alazawi@qmul.ac.uk +44 20 7882 7225 Official trial record

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