Actively Recruiting
Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)
Led by Queen Mary University of London · Updated on 2025-07-23
72
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
Q
Queen Mary University of London
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent
- Age between 45 and 65 years at consent
- HbA1c less than 48 mmol/mol
- Overweight or stage I obesity based on ethnicity-specific BMI thresholds: 23.0 to 32.4 kg/m2 for South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations; 25 to 34.9 kg/m2 for White populations
- For MASH patients: Clinical diagnosis with F2-F3 fibrosis confirmed by liver biopsy within 12 months, or history of histologically-diagnosed MASH with current fatty liver, AST > 20, and Fibroscan CAP ≥ 248 dB/m with stiffness 9.5 to 14 kPa, or FAST score > 0.67
- For steatosis patients: Fibroscan CAP ≥ 248 dB/m and stiffness less than 7.9 kPa
- For healthy controls: Fibroscan CAP less than 248 dB/m and stiffness less than 7.9 kPa
You will not qualify if you...
- Unwilling or unable to give consent
- Age under 45 or over 65 years
- Any form of diabetes mellitus
- Currently pregnant
- Known fructose intolerance or food allergy
- Diagnosis of cirrhosis or Fibroscan stiffness over 14 kPa
- Current Child-Pugh B/C or decompensation episode within the last year
- Known non-MASLD liver disease such as viral hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, or sickle cell disease
- Regular alcohol intake exceeding 14 units per week for females or 21 units per week for males
- Smoking, vaping, or use of nicotine products within the last month
- Use of prohibited medications including probiotics or antibiotics within last 4 weeks, oral steroids within last 6 weeks, immunosuppressive medications currently or within 3 months, amiodarone, nitrofurantoin, antifungals within 3 months, anti-obesity medications such as orlistat or GLP-1 receptor agonists within 6 months, vitamin E, pioglitazone, or other MASH medications currently or within 3 months unless documented placebo use
- History of malignancy (except basal cell carcinoma) or treatment for malignancy within last 2 years
- Major organ transplant except corneal or hair
- Clinical diagnosis of chronic kidney disease stage 3 or above, or heart failure NYHA class 3 or 4
- COPD requiring home oxygen
- Known eating disorder or severe mental illness
- Investigator judgment that participation is unsuitable
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
2
Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London
London, United Kingdom, E1 2AT
Actively Recruiting
Research Team
W
William Alazawi, MA(Cantab), MB, PhD
CONTACT
O
Olivia Bolton, Masters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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