[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600119":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":50,"locations":57,"responsibleParty":109,"collaborators":111,"id":114,"slug":30,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":30,"enrollmentInfo":124,"targetDuration":30,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":142,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University of Nottingham","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Pectin","ACTIVE_COMPARATOR","15g\u002Fday of pectin with 10g\u002Fday of cocoa powder added as flavour will be provided to participants for 6 weeks.",[13],"Dietary Supplement: Pectin",{"label":15,"type":16,"description":17,"interventionNames":18},"Cocoa Powder","PLACEBO_COMPARATOR","10g\u002Fday of cocoa powder will be provided to participants for 6 weeks.",[19],"Other: Cocoa Powder",{"label":21,"type":6,"description":22,"interventionNames":23},"Magnetic resonance imaging (MRI) Validation","To validate MRI scans as a tool to assess intestinal wall thickness to indicate gut permeability on MASLD patients, the investigators will scan 15 healthy volunteers twice, at baseline and after 6 weeks, and then compare their results with MASLD participant results at baseline and after 6 weeks.",[24],"Diagnostic Test: Magnetic Resonance Imaging with Contrast",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","15g of pectin with 10g of cocoa powder added as flavour were randomly allocated to eligible participants.",[9],null,{"type":6,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"10g of cocoa powder served as the control\u002F placebo to compare the effects observed with pectin.",[15],{"type":35,"name":36,"description":22,"armGroupLabels":37,"otherNames":38},"DIAGNOSTIC_TEST","Magnetic Resonance Imaging with Contrast",[21],[39],"MRI",[41,45,48],{"name":42,"affiliation":43,"role":44},"Noor K Al-Tameemi, PhD student candidate","Nottingham Digestive Diseases Centre & NIHR Nottingham Biomedical Research Centre, Nottingham, University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre Nottingham, NG7 2UH","STUDY_DIRECTOR",{"name":46,"affiliation":43,"role":47},"Guruprasad P Aithal, Professor","PRINCIPAL_INVESTIGATOR",{"name":49,"affiliation":43,"role":44},"Jane Grove, Associate Professor",[51,55],{"name":42,"role":52,"phone":53,"phoneExt":30,"email":54},"CONTACT","0044 01158231149","noorkifahabdulhussein.al-tameemi@nottingham.ac.uk",{"name":46,"role":52,"phone":53,"phoneExt":30,"email":56},"guru.aithal@nottingham.ac.uk",[58,83,96],{"facility":59,"status":60,"city":61,"state":30,"zip":62,"country":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Sir Peter Mansfield Imaging Centre, University of Nottingham","RECRUITING","Nottingham","NG7 2QX","United Kingdom",{"type":65,"coordinates":66},"Point",[67,68],-1.15047,52.9536,{"lat":68,"lon":67},[71,72,73,75,76,77,79,81],{"name":42,"role":52,"phone":53,"phoneExt":30,"email":54},{"name":46,"role":52,"phone":53,"phoneExt":30,"email":56},{"name":42,"role":74,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"name":49,"role":74,"phone":30,"phoneExt":30,"email":30},{"name":46,"role":47,"phone":30,"phoneExt":30,"email":30},{"name":78,"role":74,"phone":30,"phoneExt":30,"email":30},"Caroline Hoad",{"name":80,"role":74,"phone":30,"phoneExt":30,"email":30},"Penny Gowland, Professor",{"name":82,"role":74,"phone":30,"phoneExt":30,"email":30},"Susan Francis, Professor",{"facility":84,"status":60,"city":61,"state":30,"zip":85,"country":63,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust","NG7 2UH",{"type":65,"coordinates":87},[67,68],{"lat":68,"lon":67},[90,91,92,93,95],{"name":42,"role":52,"phone":53,"phoneExt":30,"email":54},{"name":46,"role":52,"phone":53,"phoneExt":30,"email":56},{"name":42,"role":74,"phone":30,"phoneExt":30,"email":30},{"name":94,"role":74,"phone":30,"phoneExt":30,"email":30},"Jane P Grove, Associate Professor",{"name":46,"role":47,"phone":30,"phoneExt":30,"email":30},{"facility":5,"status":60,"city":61,"state":30,"zip":85,"country":63,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},{"type":65,"coordinates":98},[67,68],{"lat":68,"lon":67},[101,102,104,105,106,107],{"name":42,"role":52,"phone":53,"phoneExt":30,"email":54},{"name":46,"role":52,"phone":53,"phoneExt":30,"email":103},"guru.aithal@nuh.nhs.uk",{"name":42,"role":74,"phone":30,"phoneExt":30,"email":30},{"name":46,"role":47,"phone":30,"phoneExt":30,"email":30},{"name":49,"role":74,"phone":30,"phoneExt":30,"email":30},{"name":108,"role":74,"phone":30,"phoneExt":30,"email":30},"Ana Valdes, Professor",{"type":110,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[112],{"name":113,"class":6},"Nottingham University Hospitals NHS Trust","100600119",false,"NCT07093346","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomised, Placebo-Controlled, Dietary Intervention Study","PEC-MASLD","Inclusion Criteria:\n\nInclusion criteria for the main study:\n\n* Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \\> 5% (e.g. histological evidence or\u002F and Transient Elastography using Controlled Attenuation Parameter (CAP)- FibroScan™ in the past month and\u002For liver imaging (such as ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI)).\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years who have a body mass index (BMI) between 18.5 and 39.9 kg\u002Fm2 and stable weight (weight gain or loss ≤ 3kg) for the past 3 months.\n* For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \\\u003C7.0% (\\\u003C53 mmol\u002Fmol) \\[1\\].\n* Able to undergo CAP-FibroScan™.\n\nInclusion criteria for healthy participants who will have MRI scans:\n\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years.\n* participants with CAP\\\u003C250 kpa\\\u003C8kP by a FibroScan™ within the past 6 months.\n\nExclusion Criteria:\n\nExclusion criteria for the main study:\n\n* Have allergy toward soya, milk or chocolate.\n* Have allergy toward pectin.\n* Participants on vegan diet.\n* Have eating disorders or difficulties or gastrointestinal conditions e.g. malabsorptive conditions such as coeliac, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.\n* Have chronic malnutrition condition.\n* History of major surgery which potentially limits participation or completion of the study.\n* History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.\n* Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.\n* Are taking the following medications: immunosuppressants, amiodarone and\u002For perhexiline.\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and\u002For program or concomitant use of any weight loss medication or herbal weight loss products.\n* History of side effects towards probiotics or prebiotics.\n* History or current psychiatric illness.\n* History or current neurological condition (e.g. epilepsy).\n* Participants with other liver abnormalities.\n* Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.\n* Have had a weight change exceeding 3 kg within 3 months.\n* Uncontrolled diabetes, active malignancy, or chronic infections.\n* Having symptoms of active infection.\n* Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.\n* Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.\n* Participation in any other trial in the last 3 months.\n\nExclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:\n\n* Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.\n* Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.",true,"ALL","18 Years",{"count":125,"type":126},45,"ESTIMATED","INTERVENTIONAL",[129],"NA","The goal of this clinical trial is to learn if daily supplementation with Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), can reduce systemic inflammation and improve gut microbiota composition in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The main question it aims to answer is:\n\n-How does dietary Low-methoxy (LM) pectin supplementation affect systematic inflammation pathways such as those mediated by gut microbiota composition and what are the impacts on general metabolic indicators in individuals with MASLD?\n\nResearchers will compare a group taking 15g of LM-pectin with 10g of cocoa powder to a placebo group receiving 10g of placebo with 10g of cocoa powder to see if LM-pectin has measurable effects on inflammation and gut microbiota.\n\nParticipants will:\n\n* Take a daily supplement for 6 weeks: either 15g of LM-pectin with 10g of cocoa powder (intervention), or 10g of placebo with 10g of cocoa powder (control)\n* Provide stool and fasting blood samples before and after the intervention\n* Undergo anthropometric measurements (weight, height, waist\u002Fhip ratio, and blood pressure)\n* Complete a case report form (CRF) including demographics and health\u002Fmedical history\n* Undergo a FibroScan™ to assess liver health\n* (Optional) Participate in MRI scans to evaluate gut permeability",[132,133,134,135,136,137,138,139,140,141],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease (NAFLD)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD","NAFLD","Metabolic Dysfunction-Associated Steatotic Liver Disease","NAFLD (Nonalcoholic Fatty Liver Disease)","NAFLD (Non-alcoholic Fatty Liver Disease)","NAFLD - Non-Alcoholic Fatty Liver Disease","NAFLD - Nonalcoholic Fatty Liver Disease",[143,144,135,136,132,145,146,147,148,149,137],"LM pectin","pectin","Systemic Inflammatory Response","Dietary Fiber","Dietary Fibre","Diet","gut microbiota","2025-07-22",{"date":152,"type":153},"2025-07-30","ACTUAL",{"date":155,"type":153},"2025-06-10",{"date":157,"type":126},"2027-03-31",{"name":5,"class":6},3]