[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594013":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":65,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fructose supplementation","ACTIVE_COMPARATOR","Participants will consume 100 g\u002Fday of fructose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet",[13],"Dietary Supplement: fructose",{"label":15,"type":10,"description":16,"interventionNames":17},"Glucose supplementation","Participants will consume 100 g\u002Fday of glucose powder administered as two 50g sachets, dissolved in water in addition to following a low-sugar diet",[18],"Dietary Supplement: glucose",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","fructose","Fructose powder",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"glucose","Glucose powder",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"William Alazawi, MA(Cantab), MB, PhD","CONTACT","+44 20 7882 7225","w.alazawi@qmul.ac.uk",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Olivia Bolton, Masters","+44 20 788 23916","o.bolton@qmul.ac.uk",[41,57],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Royal London Hospital","RECRUITING","London","E1 1FR","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.12574,51.50853,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":34,"phoneExt":25,"email":35},"William Alazawi",{"facility":58,"status":43,"city":44,"state":25,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London","E1 2AT",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68,70],{"name":69,"class":6},"King's College London",{"name":71,"class":6},"University of Surrey","100594013","fructose-is-a-metabolic-and-inflammatory-pathogenic-factor-in-metabolic-dysfunction-associated-steatohepatitis-mash-100594013",false,"NCT07013916","Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)","FLOURISH","Inclusion Criteria:\n\n* Able and willing to give written informed consent\n* Age 45-65 at consent\n* HbA1c \\\u003C 48 mmol\u002Fmol\n* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:\n\n  * 23.0kg\u002Fm2 - 32.4kg\u002Fm2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations\n  * 25kg\u002Fm2 - 34.9kg\u002Fm2 in White populations\n\nMASH Patients:\n\nClinical diagnosis of MASH and F2 - F3 fibrosis:\n\nEither:\n\nLiver biopsy within 12 months of baseline\n\nOr:\n\n• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\\>20 and Fibroscan CAP≥248 dB\u002Fm and stiffness 9.5kPa -14kPa\n\nOr:\n\n• FAST score \\>0.67\n\nPatients with steatosis:\n\n• defined by Fibroscan CAP≥248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nHealthy controls:\n\n• defined by Fibroscan CAP\\\u003C248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Age \\\u003C45 or \\>65\n* Any form of diabetes mellitus\n* Currently pregnant\n* Known fructose intolerance or food allergy\n* Diagnosis of cirrhosis or Fibroscan stiffness \\>14kPa\n* Current Child-Pugh B\u002FC or episode of decompensation in last year\n* 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)\n* Regular alcohol intake \\> 14 units a week for females and \\>21 units a week for males (participant-reported)\n* Smoking, vaping or use of nicotine-containing products within the last month\n* Taking prohibited medication:\n\n  * 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)\n  * any oral steroids within the last 6 weeks\n  * current, or within 3 months, use of immunosuppressive medication\n  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months\n  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months\n  * 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\n* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years\n* Any major organ transplant (excluding corneal or hair)\n* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)\n* COPD requiring home oxygen\n* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)\n* Investigator opinion that study is unsuitable for patient",true,"ALL","45 Years","65 Years",{"count":84,"type":85},72,"ESTIMATED","INTERVENTIONAL",[88],"NA","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.\n\nIt 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.\n\nTo 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\u002FMASH.",[91,92,93],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","MASH With Fibrosis","Steatosis of Liver",[22,95,96,97,98],"MASH","MASLD","liver","inflammation","2025-07-18",{"date":101,"type":102},"2025-07-23","ACTUAL",{"date":104,"type":102},"2025-06-30",{"date":106,"type":85},"2026-04-01",{"name":5,"class":6},2]