Does fructose worsen metabolism and liver inflammation in people with MASH?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a four-week, randomized, double-blind, parallel-arm food supplement intervention comparing the metabolic and inflammatory effects of fructose versus glucose in three groups: people with MASH (F2–F3 fibrosis), people with simple steatosis, and healthy controls. Participants aged 45–65 who are overweight or have stage I obesity will attend up to five visits including long baseline and post-intervention visits with standardized test meals and hourly blood sampling over about six hours. A subset of up to 24 participants will take part in an optional sub-study using a small stable isotope tracer to trace how fructose or glucose is metabolized after a meal. All primary visits are in-person and involve FibroScan or prior biopsy records to confirm liver status and frequent blood-based measurements of metabolic and inflammatory markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able and willing to give written informed consent
* Age 45-65 at consent
* HbA1c \< 48 mmol/mol
* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:

  * 23.0kg/m2 - 32.4kg/m2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations
  * 25kg/m2 - 34.9kg/m2 in White populations

MASH Patients:

Clinical diagnosis of MASH and F2 - F3 fibrosis:

Either:

Liver biopsy within 12 months of baseline

Or:

• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\>20 and Fibroscan CAP≥248 dB/m and stiffness 9.5kPa -14kPa

Or:

• FAST score \>0.67

Patients with steatosis:

• defined by Fibroscan CAP≥248dB/m and stiffness \<7.9kPa.

Healthy controls:

• defined by Fibroscan CAP\<248dB/m and stiffness \<7.9kPa.

Exclusion Criteria:

* Unwilling or unable to give consent
* Age \<45 or \>65
* Any form of diabetes mellitus
* Currently pregnant
* Known fructose intolerance or food allergy
* Diagnosis of cirrhosis or Fibroscan stiffness \>14kPa
* Current Child-Pugh B/C or episode of decompensation in last year
* Non-MASLD liver disease known to participant (including viral hepatitis, auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, sickle cell disease)
* Regular alcohol intake \> 14 units a week for females and \>21 units a week for males (participant-reported)
* Smoking, vaping or use of nicotine-containing products within the last month
* Taking prohibited medication:

  * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use)
  * any oral steroids within the last 6 weeks
  * current, or within 3 months, use of immunosuppressive medication
  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months
  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months
  * Use of vitamin E, pioglitazone or other medication for MASH including current or within 3 months enrolment in clinical trial unless documented to have been on placebo
* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years
* Any major organ transplant (excluding corneal or hair)
* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)
* COPD requiring home oxygen
* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)
* Investigator opinion that study is unsuitable for patient

Where it's running

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

Study contacts

• Study coordinator: William Alazawi, MA(Cantab), MB, PhD
• Email: w.alazawi@qmul.ac.uk
• Phone: +44 20 7882 7225

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Resmetirom in children and teens with MASH

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.