Actively Recruiting
Fructose as a Metabolic and Inflammatory 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
N/A
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
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common liver condition caused by fat buildup, which in some people leads to inflammation and damage known as metabolic dysfunction-associated steatohepatitis (MASH). MASH increases the risk of severe liver problems like cirrhosis and cancer. Researchers want to understand why MASLD progresses to MASH and suspect that diet, especially fructose intake, may play a role. This study compares the effects of fructose and glucose on people with MASH, MASLD, and healthy controls to see if fructose worsens inflammation and liver health. The study is a four-week randomized, double-blind trial where participants first follow a low-sugar diet for two weeks, then take either 100g of fructose or glucose daily for 14 days while continuing the low-sugar diet. Participants consume the sugar supplements dissolved in water between meals. There are up to five visits including consent, screening, baseline, pre-intervention, and post-intervention. Some participants may join an optional sub-study involving special tracer sugars to study metabolism in more detail. Throughout the study, participants will have blood, urine, stool, and saliva samples collected, and undergo metabolic testing with a standardized meal and frequent blood draws over 6 hours. Researchers will measure markers of inflammation, metabolism, liver fat, gut microbiota, and other factors related to MASLD and MASH. Participants receive dietary support and complete food diaries. The study will last about four weeks, and any important health findings will be shared with their doctors.
CONDITIONS
Brief 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 BMI thresholds adjusted for ethnicity
- Clinical diagnosis of MASH with fibrosis stage F2 to F3 confirmed by biopsy within 12 months or specific Fibroscan and blood test criteria
- Patients with steatosis defined by Fibroscan CAP ≥248 dB/m and stiffness <7.9 kPa
- Healthy controls defined by Fibroscan CAP <248 dB/m and stiffness <7.9 kPa
You will not qualify if you...
- Unwilling or unable to give consent
- Age younger than 45 or older than 65 years
- Any form of diabetes mellitus
- Currently pregnant
- Known fructose intolerance or food allergy
- Diagnosis of cirrhosis or Fibroscan stiffness >14 kPa
- Current Child-Pugh B/C or recent liver decompensation
- Known non-MASLD liver diseases such as viral hepatitis or autoimmune hepatitis
- Regular alcohol intake exceeding 14 units/week for females or 21 units/week for males
- Smoking, vaping, or nicotine product use within the last month
- Use of prohibited medications including recent antibiotics, probiotics, steroids, immunosuppressants, certain liver-related drugs, or anti-obesity treatments
- History of malignancy or treatment within the last 2 years except basal cell carcinoma
- Major organ transplant except corneal or hair
- Chronic kidney disease stage 3 or higher, or severe heart failure
- COPD requiring home oxygen
- Known eating disorders or severe mental illness
- Investigator judgement that study participation is unsuitable
AI-Screening
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Your Study Journey
Duration - Up to 3 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and consent if combined, otherwise 2 visits
Duration - 2 weeks
Participants follow a personalized low-sugar diet with dietary counselling and support to prepare for the supplementation phase.
1 baseline visit before starting the diet
Duration - 14 days
Participants continue the low-sugar diet and receive daily supplementation with either fructose or glucose powder for 14 days.
1 pre-intervention visit and 1 post-intervention visit with 6-hour metabolic test meal and blood sampling each
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
O
Olivia Bolton, Masters
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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