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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorQueen Mary University of London

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able and willing to give written informed consent

Age 45-65 at consent

HbA1c < 48 mmol/mol

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

Disqualifiers

Unwilling or unable to give consent

Age <45 or >65

Any form of diabetes mellitus

Currently pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • fructose

    Dietary supplement

    Fructose powder

  • glucose

    Dietary supplement

    Glucose powder

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Fructose supplementationActive comparator 1 intervention
Group B: Glucose supplementationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in plasma glutamate concentration

Difference in the fructose-induced changes in plasma glutamate concentration in patients with MASH and fibrosis compared to patients with simple steatosis (without fibrosis) or healthy controls.

Time frame
Changes from baseline to week 2

Secondary outcomes

1

Plasma metabolome

Changes in plasma metabolome from blood samples measured by mass spectrometry

Time frame
Changes from baseline to week 2
2

Urine metabolome

Changes in urine metabolome measured by mass spectrometry

Time frame
Changes from baseline to week 2
3

Plasma glucose

Changes in fasting and post-prandial plasma glucose (mmol/L)

Time frame
Changes from baseline to week 2
4

Plasma triglycerides

Change in fasting and post-prandial plasma triglycerides (mmol/L)

Time frame
Changes from baseline to week 2

Other outcomes

1

Genetic variants

Measures of genetic variants relevant to MASLD/MASH and/or relevant metabolic processes, including sugar digestion/metabolism, inflammation, and/or liver metabolism.

Time frame
Changes from baseline to week 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary University of London

Lead sponsor

King's College London

Collaborator

University of Surrey

Collaborator