MASH - Metabolic Dysfunction-Associated SteatohepatitisFLOURISHNCT07013916
Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)
A study testing fructose and glucose in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and MASH With Fibrosis, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASH With Fibrosis, Steatosis of Liver
- What is being tested?
- fructose and glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Jun 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal London Hospital
London, E1 1FR
William Alazawi, +44 20 7882 7225, w.alazawi@qmul.ac.uk
- Recruiting
Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London
London, E1 2AT
William Alazawi, MA(Cantab), MB, PhD, +44 20 7882 7225, w.alazawi@qmul.ac.uk
About this study
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.
Read the detailed description
Overview of the study:
This is a four-week randomised double-blind parallel-arm food supplement intervention study that will determine the effect of fructose on metabolism in people with MASH, compared to people with simple steatosis, or controls without liver disease. The study will involve consent (visit 0A) and screening (visit 0B), followed by two study stages (see Figure 1), where participants will undergo study visits and procedures as detailed in Table 1. Each participant will attend for a total of up to 5 study visits: consent (visit 0A) and screening (visit 0B); Baseline (visit 1); pre-intervention (visit 2); post-intervention (visit 3). Consent (visit 0A) and screening (visit 0B) visits may be combined into one visit if feasible and the participant would like to do so. Otherwise, visits will be conducted on separate days as close together as practical for the participant and research team (ideally no more than 3-4 weeks). Visits 1 to 3 will each last approximately 8 hours, at which participants will consume a test meal and have hourly blood samples taken via a cannula for approximately 6h.
A subset of participants (maximum of n=24; n=12 MASH; n=12 steatosis/control) will be invited to take part in an optional sub-study. This will involve the same study visits and procedures as the main study but will additionally measure how glucose or fructose is metabolised in the postprandial state by addition of a small amount of glucose/fructose stable isotope tracer (13C6-fructose or 13C6-glucose) to the metabolic test meal. Participants will also provide breath samples at hourly intervals during the 6h feeding period.
There will be no change to routine patient care for MASH and MASLD participants during the study period. Any clinically significant results emerging from study participation will be shared with participants' GP or care team.
Description of the study intervention:
Following consent (visit 0A) and screening (visit 0B), participants will receive a study guide with details of the main study visits and procedures, and instructions on how to complete the 3-day food diaries. At the baseline visit (visit 1), participants will receive dietary counselling and other information to help them follow a diet low in free sugars, including fructose, glucose, and sucrose. The nutrition researcher and participant will agree on a personalised list of suggested low-sugar meals, drinks and snacks that are suitable to be consumed during the study. Participants will be given a choice of food, drink and snack items to be delivered each two weeks as the basis for a low-sugar diet. The nutrition researcher will offer ongoing support to ensure compliance via regular phone calls, messages, and at study visits as needed.
Following the Baseline visit (visit 1), participants will undergo a two-week run-in period on the low-sugar diet, after which they will be randomised to either group A or B for the supplementation period. Both groups will be maintained on the low-sugar diet and additionally receive supplemental 100g of fructose (group A) or glucose (group B) per day for a period of 14 days. All sachets will be labelled as 'Sugar Supplement' or similar.
Each 100g daily dose of glucose or fructose will be prepared by an independent researcher at King's College London and divided into two labelled sachets (50g each). Participants will be directed to dissolve each of the sugar sachets in approximately 300 ml of water and to consume these solutions in between their primary meals. All study participants will be provided with a daily multivitamin supplement to prevent any risk of nutrient deficiencies due to the low fruit content of the prescribed diet.
Dietary intake will be analysed through a series of 3-day food diaries completed contemporaneously prior to each of the study visits (baseline, pre- and post-intervention). The UK Composition of Foods Integrated Dataset will be used to compute the macro- and micronutrient composition, as well as the caloric value, of the diet. The dietary intervention will be compiled by an expert nutrition researcher and overseen by a qualified dietitian.
Participants will attend five study visits, including consent (visit 0A) and screening (visit 0B), a baseline visit (visit 1; before starting the low-sugar diet), as well as visits pre-intervention (visit 2) and post-intervention (visit 3), as detailed in section 7.3. Consent (visit 0A) and screening (visit 0B) visits may be combined into one visit if feasible and the participant would like to do so.
Participants will be remunerated for their time and commitment to completing the study procedures.
Visits for the study:
Pre-screening: Potential participants will be recruited from liver clinics (MASH and steatotic patients) or via the PIC site (King's College Hospital); control (healthy) participants will be recruited via email or poster adverts. All potential participants will receive a copy of the Participant Information Sheet and be given time to read and consider this. Prior to attending for a consent or screening visit, potential participants will undergo a pre-screening call or discussion with either a member of their clinical care team (MASH/steatosis patients) or a member of the study research team (controls) to check their eligibility against the inclusion/exclusion criteria prior to attending in person.
Consent (Visit 0A): Prior to the consent visit, participants will receive the participant information sheet and have the opportunity to consider this (and discuss it with others if they wish). Participants will attend for the visit and have the opportunity to ask questions or discuss the study with a member of the research team, before offering their informed consent. Participants will receive a copy of their signed consent form and agree on a suitable date for the screening visit.
Screening (visit 0B): Participants will answer questions concerning medical history, have anthropometrics and vital signs measured by a researcher, and (if required to confirm eligibility) have a Fibroscan and fasted blood sample taken. Participants will be informed of their eligibility following the visit and be provided with a copy of the study guide, which includes instructions on how to complete the 3-day food diaries.
Visits 1, 2 and 3: Participants will be sent a reminder to complete each of the 3-day food diaries prior to each visit. They will also be given a low-fat standardised meal to consume the night before and will attend in the morning (at approximately 8am) after an overnight fast (≥12h). Participants will provide fresh stool, urine, and saliva samples, and researchers will take anthropometric measurements and vital signs (e.g. blood pressure). Measurements will be conducted utilising Vibration-Controlled Transient Elastography with Controlled Attenuation Parameter (VCTE CAP).
Participants will then undergo a 6-hour post-prandial feeding protocol, which will measure the metabolic response to consuming a standardised mixed nutrient test meal. Participants will be cannulated and have fasted blood samples taken, before consuming the mixed-nutrient meal. Blood samples will be taken every hour over the subsequent 6-hour period to test metabolic response to the test meal, including markers of lipid and glucose metabolism. Participants will not be able to eat anything else during this period but will be offered ad libitum drinking water.
In the optional sub-study, participants will additionally consume 13C6-glucose or 13C6-fructose stable isotope tracer as part of the test meal and provide breath samples at hourly intervals, in addition to the hourly blood samples. This will allow the metabolism of glucose and fructose to be measured in blood (13C-palmitate for de novo lipogenesis) and breath (13CO2 for glucose/fructose oxidation) samples to provide additional insight into how the sugars are metabolised.
Following the post-prandial procedure, the cannula will be removed. Participants will be offered something to eat, given any additional instructions, dietary counselling, or study supplies required for the next stage of the study and will then be able to leave.
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASH With Fibrosis, Steatosis of Liver
- Being tested
- fructose, glucose
- Keywords
- fructose, MASH, MASLD, liver, inflammation
- Medical subject headings
- Fatty Liver, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fructoseDietary supplement
Fructose powder
glucoseDietary supplement
Glucose powder
| Study group | Role | What they receive |
|---|---|---|
| Fructose supplementation | Active comparator | Participants will consume 100 g/day of fructose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet Receives: Dietary Supplement: fructose |
| Glucose supplementation | Active comparator | Participants will consume 100 g/day of glucose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet Receives: Dietary Supplement: glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline to week 2
Secondary outcomes (13)
Plasma metabolome
Changes in plasma metabolome from blood samples measured by mass spectrometry
Measured: Changes from baseline to week 2
Urine metabolome
Changes in urine metabolome measured by mass spectrometry
Measured: Changes from baseline to week 2
Plasma glucose
Changes in fasting and post-prandial plasma glucose (mmol/L)
Measured: Changes from baseline to week 2
Plasma triglycerides
Change in fasting and post-prandial plasma triglycerides (mmol/L)
Measured: Changes from baseline to week 2
Serum insulin
Change in fasting and post-prandial serum insulin (pmol/L)
Measured: Changes from baseline to week 2
De novo lipogenesis
Change in absolute fasting and post-prandial de novo lipogenesis measured as 13C-palmitate in plasma triglyceride-rich lipoproteins (µmol/L)
Measured: Changes from baseline to week 2
Liver function markers
Changes in liver function enzymes (ALT, AST, ALP, GGT), albumin and bilirubin
Measured: Changes from baseline to week 2
Gut hormones
Changes in hormones relevant to gut function (e.g. digestion) and/or physiology, measured using standardised tests.
Measured: Changes from baseline to week 2
Oral microbiome
Changes in oral microbiome measured from saliva samples using 16S sequencing
Measured: Changes from baseline to week 2
Oral metabolites
Changes in metabolites from saliva samples measured using mass spectrometry
Measured: Changes from baseline to week 2
Markers of inflammation
Changes in markers of inflammation
Measured: Changes from baseline to week 2
Markers of immunity
Changes in markers of immune function
Measured: Changes from baseline to week 2
Markers of cell function
Changes in markers of cell function
Measured: Changes from baseline to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start30 Jun 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASH - Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a four-week randomised double-blind parallel-arm food supplement intervention study that will determine the effect of fructose (arm 1) and glucose (arm 2) on metabolism in people with MASH (n=36), compared to people with simple steatosis (n=18), or controls without liver disease (n=18).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Surrey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013916
- Sponsor's protocol ID
- 344872
- Acronym
- FLOURISH
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT07013916
- Acronym / sponsor ID
- FLOURISH / 344872
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASH With Fibrosis, Steatosis of Liver
- Keywords
- fructose, MASH, MASLD, liver, inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- King's College London, University of Surrey
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview of the study:
This is a four-week randomised double-blind parallel-arm food supplement intervention study that will determine the effect of fructose on metabolism in people with MASH, compared to people with simple steatosis, or controls without liver disease. The study will involve consent (visit 0A) and screening (visit 0B), followed by two study stages (see Figure 1), where participants will undergo study visits and procedures as detailed in Table 1. Each participant will attend for a total of up to 5 study visits: consent (visit 0A) and screening (visit 0B); Baseline (visit 1); pre-intervention (visit 2); post-intervention (visit 3). Consent (visit 0A) and screening (visit 0B) visits may be combined into one visit if feasible and the participant would like to do so. Otherwise, visits will be conducted on separate days as close together as practical for the participant and research team (ideally no more than 3-4 weeks). Visits 1 to 3 will each last approximately 8 hours, at which participants will consume a test meal and have hourly blood samples taken via a cannula for approximately 6h.
A subset of participants (maximum of n=24; n=12 MASH; n=12 steatosis/control) will be invited to take part in an optional sub-study. This will involve the same study visits and procedures as the main study but will additionally measure how glucose or fructose is metabolised in the postprandial state by addition of a small amount of glucose/fructose stable isotope tracer (13C6-fructose or 13C6-glucose) to the metabolic test meal. Participants will also provide breath samples at hourly intervals during the 6h feeding period.
There will be no change to routine patient care for MASH and MASLD participants during the study period. Any clinically significant results emerging from study participation will be shared with participants' GP or care team.
Description of the study intervention:
Following consent (visit 0A) and screening (visit 0B), participants will receive a study guide with details of the main study visits and procedures, and instructions on how to complete the 3-day food diaries. At the baseline visit (visit 1), participants will receive dietary counselling and other information to help them follow a diet low in free sugars, including fructose, glucose, and sucrose. The nutrition researcher and participant will agree on a personalised list of suggested low-sugar meals, drinks and snacks that are suitable to be consumed during the study. Participants will be given a choice of food, drink and snack items to be delivered each two weeks as the basis for a low-sugar diet. The nutrition researcher will offer ongoing support to ensure compliance via regular phone calls, messages, and at study visits as needed.
Following the Baseline visit (visit 1), participants will undergo a two-week run-in period on the low-sugar diet, after which they will be randomised to either group A or B for the supplementation period. Both groups will be maintained on the low-sugar diet and additionally receive supplemental 100g of fructose (group A) or glucose (group B) per day for a period of 14 days. All sachets will be labelled as 'Sugar Supplement' or similar.
Each 100g daily dose of glucose or fructose will be prepared by an independent researcher at King's College London and divided into two labelled sachets (50g each). Participants will be directed to dissolve each of the sugar sachets in approximately 300 ml of water and to consume these solutions in between their primary meals. All study participants will be provided with a daily multivitamin supplement to prevent any risk of nutrient deficiencies due to the low fruit content of the prescribed diet.
Dietary intake will be analysed through a series of 3-day food diaries completed contemporaneously prior to each of the study visits (baseline, pre- and post-intervention). The UK Composition of Foods Integrated Dataset will be used to compute the macro- and micronutrient composition, as well as the caloric value, of the diet. The dietary intervention will be compiled by an expert nutrition researcher and overseen by a qualified dietitian.
Participants will attend five study visits, including consent (visit 0A) and screening (visit 0B), a baseline visit (visit 1; before starting the low-sugar diet), as well as visits pre-intervention (visit 2) and post-intervention (visit 3), as detailed in section 7.3. Consent (visit 0A) and screening (visit 0B) visits may be combined into one visit if feasible and the participant would like to do so.
Participants will be remunerated for their time and commitment to completing the study procedures.
Visits for the study:
Pre-screening: Potential participants will be recruited from liver clinics (MASH and steatotic patients) or via the PIC site (King's College Hospital); control (healthy) participants will be recruited via email or poster adverts. All potential participants will receive a copy of the Participant Information Sheet and be given time to read and consider this. Prior to attending for a consent or screening visit, potential participants will undergo a pre-screening call or discussion with either a member of their clinical care team (MASH/steatosis patients) or a member of the study research team (controls) to check their eligibility against the inclusion/exclusion criteria prior to attending in person.
Consent (Visit 0A): Prior to the consent visit, participants will receive the participant information sheet and have the opportunity to consider this (and discuss it with others if they wish). Participants will attend for the visit and have the opportunity to ask questions or discuss the study with a member of the research team, before offering their informed consent. Participants will receive a copy of their signed consent form and agree on a suitable date for the screening visit.
Screening (visit 0B): Participants will answer questions concerning medical history, have anthropometrics and vital signs measured by a researcher, and (if required to confirm eligibility) have a Fibroscan and fasted blood sample taken. Participants will be informed of their eligibility following the visit and be provided with a copy of the study guide, which includes instructions on how to complete the 3-day food diaries.
Visits 1, 2 and 3: Participants will be sent a reminder to complete each of the 3-day food diaries prior to each visit. They will also be given a low-fat standardised meal to consume the night before and will attend in the morning (at approximately 8am) after an overnight fast (≥12h). Participants will provide fresh stool, urine, and saliva samples, and researchers will take anthropometric measurements and vital signs (e.g. blood pressure). Measurements will be conducted utilising Vibration-Controlled Transient Elastography with Controlled Attenuation Parameter (VCTE CAP).
Participants will then undergo a 6-hour post-prandial feeding protocol, which will measure the metabolic response to consuming a standardised mixed nutrient test meal. Participants will be cannulated and have fasted blood samples taken, before consuming the mixed-nutrient meal. Blood samples will be taken every hour over the subsequent 6-hour period to test metabolic response to the test meal, including markers of lipid and glucose metabolism. Participants will not be able to eat anything else during this period but will be offered ad libitum drinking water.
In the optional sub-study, participants will additionally consume 13C6-glucose or 13C6-fructose stable isotope tracer as part of the test meal and provide breath samples at hourly intervals, in addition to the hourly blood samples. This will allow the metabolism of glucose and fructose to be measured in blood (13C-palmitate for de novo lipogenesis) and breath (13CO2 for glucose/fructose oxidation) samples to provide additional insight into how the sugars are metabolised.
Following the post-prandial procedure, the cannula will be removed. Participants will be offered something to eat, given any additional instructions, dietary counselling, or study supplies required for the next stage of the study and will then be able to leave.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a four-week randomised double-blind parallel-arm food supplement intervention study that will determine the effect of fructose (arm 1) and glucose (arm 2) on metabolism in people with MASH (n=36), compared to people with simple steatosis (n=18), or controls without liver disease (n=18).
| Arm | Type | Receives |
|---|---|---|
| Fructose supplementation | Active comparator | Dietary Supplement: fructoseParticipants will consume 100 g/day of fructose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet |
| Glucose supplementation | Active comparator | Dietary Supplement: glucoseParticipants will consume 100 g/day of glucose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Liver biopsy within 12 months of baseline
Key exclusion criteria (23 listed)
- Unwilling or unable to give consent
- Age <45 or >65
- Any form of diabetes mellitus
- Currently pregnant
- Known fructose intolerance or food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fructoseFructose powder | Dietary supplement | Fructose supplementation |
| glucoseGlucose powder | Dietary supplement | Glucose supplementation |
Primary outcome
Change in plasma glutamate concentration
Time frame: Changes from baseline to week 2
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.
13 secondary outcomes
Plasma metabolome
Time frame: Changes from baseline to week 2
Urine metabolome
Time frame: Changes from baseline to week 2
Plasma glucose
Time frame: Changes from baseline to week 2
Plasma triglycerides
Time frame: Changes from baseline to week 2
Serum insulin
Time frame: Changes from baseline to week 2
De novo lipogenesis
Time frame: Changes from baseline to week 2
Liver function markers
Time frame: Changes from baseline to week 2
Gut hormones
Time frame: Changes from baseline to week 2
Oral microbiome
Time frame: Changes from baseline to week 2
Oral metabolites
Time frame: Changes from baseline to week 2
Markers of inflammation
Time frame: Changes from baseline to week 2
Markers of immunity
Time frame: Changes from baseline to week 2
Markers of cell function
Time frame: Changes from baseline to week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
RecruitingPhase 3
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fructose and glucose in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis and MASH With Fibrosis, run by Queen Mary University of London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Alazawi, MA(Cantab), MB, PhD (+44 20 7882 7225, w.alazawi@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma glutamate concentration (time frame: Changes from baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.