The FLOURISH study v1.0

• Research type

  Research Study

• Full title

  Fructose is a metabolic and inflammatory pathogenic factor in metabolic dysfunction-associated steatohepatitis (MASH)

• IRAS ID

  344872

• Contact name

  William Alazawi

• Contact email

  w.alazawi@qmul.ac.uk

• Sponsor organisation

  Queen Mary, University of London

• Duration of Study in the UK

  1 years, 1 months, 1 days

• Research summary

  Metabolic dysfunction-associated liver disease (MASLD) is the most common cause of chronic liver disease worldwide. Metabolic dysfunction-associated steatohepatitis (MASH) occurs when MASLD progresses, causing inflammation and damage to the liver. People with MASH are at greater risk of liver disease progression and cirrhosis.
  Studies have shown that a high-fructose diet is associated with liver fat accumulation and insulin resistance, although no studies have included people with MASH. Our main research question is whether fructose promotes a more pro-inflammatory profile in people with MASH and fibrosis compared to those with simple steatosis or without liver disease. We will also investigate fructose effects on liver fat content, microbiota, and other processes relevant to MASLD/MASH. This is a four-week randomised, double-blind parallel-arm food supplement intervention study to determine fructose effects on metabolism in people with MASH, compared to people with simple steatosis, or controls without liver disease (n=72; n=36 MASH patients, n=18 steatosis patients and n=18 healthy controls). The study has two stages, each lasting 14 days. Throughout both stages participants will be required to follow a low-sugar diet, and in the second stage they will also be asked to consume a sugar supplement of either glucose of fructose. Participants will be required to attend 3 study visits. Each study visit lasts ~8 hours, where participants will provide stool, urine and saliva samples, in addition to hourly blood samples taken via cannulation. We will also conduct a sub-study where we will invite participants to consume a 13C-glucose or 13C-fructose stable isotope tracer and provide breath samples at hourly intervals. Participants will be reimbursed £400, and we will make a significant contribution to their grocery shops. There will be no change to routine patient care for participants during the study and any clinically significant results emerging from participation will be shared with participants' GP/care team.

• REC name

  West of Scotland REC 3

• REC reference

  25/WS/0046

• Date of REC Opinion

  2 May 2025

• REC opinion

  Further Information Favourable Opinion