[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559422":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":82,"locations":34,"responsibleParty":87,"collaborators":91,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":34,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":34,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":122,"whyStopped":34,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":34},{"fullName":5,"class":6},"Nicolaus Copernicus University","OTHER",[8,15,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: probiotics supplementation + physical exercise program","EXPERIMENTAL","Behavioral: physical exercise program in the form of a resistance\u002Fhypertrophy-oriented resistance program Dietary Supplement: probiotics supplementation",[13,14],"Behavioral: physical exercise programme","Dietary Supplement: probiotics supplementation",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator: placebo + resistance\u002Fhypertrophy-oriented resistance program plus placebo","ACTIVE_COMPARATOR","placebo + resistance\u002Fhypertrophy-oriented resistance program",[13,20],"Dietary Supplement: Placebo",{"label":22,"type":10,"description":14,"interventionNames":23},"probiotics supplementation",[14],{"label":25,"type":26,"description":25,"interventionNames":27},"placebo","PLACEBO_COMPARATOR",[20],[29,35,38],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","physical exercise programme","resistance\u002Fhypertrophy-oriented resistance programme",[16,9],null,{"type":36,"name":22,"description":22,"armGroupLabels":37,"otherNames":34},"DIETARY_SUPPLEMENT",[9,22],{"type":36,"name":39,"description":39,"armGroupLabels":40,"otherNames":34},"Placebo",[16,25],[42,46,49,51,54,57,60,62,65,67,70,72,74,76,78,80],{"name":43,"affiliation":44,"role":45},"Lynette Hodges, PhD","Massey University, New Zealand","STUDY_CHAIR",{"name":47,"affiliation":48,"role":45},"Beata Januszko-Giergielewicz, Assoc. Prof.","Nicolaus Copernicus University, Poland",{"name":50,"affiliation":48,"role":45},"Maciej Słupski, Prof.",{"name":52,"affiliation":53,"role":45},"Karolina Skonieczna-Żydecka, Prof.","Pomeranian Medical University in Szczecin, Poland",{"name":55,"affiliation":56,"role":45},"Agnieszka Cudnoch-Jędrzejewska, Prof.","Warsaw Medical University, Poland",{"name":58,"affiliation":48,"role":59},"Sławomir Kujawski, PhD","STUDY_DIRECTOR",{"name":61,"affiliation":48,"role":45},"Joanna Słomko, Prof.",{"name":63,"affiliation":64,"role":45},"Karl J. Morten, Prof.","Oxford University, UK",{"name":66,"affiliation":48,"role":45},"Hanna Tabisz, MSc",{"name":68,"affiliation":69,"role":45},"Magdalena Krintus, prof","Nicolaus Copernicus Univeristy",{"name":71,"affiliation":69,"role":45},"Sławomir Manysiak, PhD",{"name":73,"affiliation":69,"role":45},"Aleksandra Modlińska",{"name":75,"affiliation":69,"role":45},"Przemysław Ratajczak, MD",{"name":77,"affiliation":69,"role":45},"Agnieszka Radzimińska",{"name":79,"affiliation":69,"role":45},"Wojciech Kazimierczak",{"name":81,"affiliation":69,"role":45},"Elżbieta Zawada",[83],{"name":58,"role":84,"phone":85,"phoneExt":34,"email":86},"CONTACT","0048791448117","skujawski@cm.umk.pl",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Prof. Paweł Zalewski, PhD","Prof.",[92,94],{"name":93,"class":6},"University of Oxford",{"name":95,"class":6},"Medical University of Warsaw","100559422","re-and-probiotics-in-mafldnafld-100559422",false,"NCT06563921","RE and Probiotics in MAFLD\u002FNAFLD","PRObiotic Mixed With Exercise THErapy USe in MAFLD (PROMETHEUS in MAFLD)","Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD\u002FMAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods.\n\nInclusion criteria:\n\n* Diagnosis of NAFLD\u002FMAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)\n* Age 18-60 years\n* Ability to understand the study procedures and provide informed consent.\n* Stable clinical condition for at least 3 months prior to study initiation.\n\nExclusion criteria:\n\n* Lack of fluency in English or Polish\n* Significant (structural) limitation of upper and\u002For lower limb mobility\n* Pregnancy or breastfeeding\n* Inability to understand instructions\n* Shift work\n* Participation in any study or research project within the last 3 months\n* Participation in an interventional drug study within the last 3 months\n* Participants with hepatic steatosis and regular alcohol consumption \\> 30 g\u002Fday\n* Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic\u002Fgenetic diseases (e.g., Wilson's disease))\n* Anticoagulant\u002Fantiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \\\u003C 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment\n* Use of medications such as steroids, methotrexate, metformin\n* Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)\n* Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \\[e.g., cervical\\] or benign skin cancer), unless complete remission has been achieved\n* Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment\n* Known allergy to probiotics\n* History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry\n* Previous surgery (bariatric surgery, gastric or intestinal resection)\n* Parenteral nutrition (TPN) within the last 6 months\n* Insulin therapy\n* Uncontrolled diabetes\n* Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance)\n* Nervous system disorders\n* Cognitive impairment and dementia\n* Osteoporosis\u002Fosteopenia\n* Active thyroid disease\n* Cushing's syndrome\n* Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)","ALL","18 Years","60 Years",{"count":107,"type":108},180,"ESTIMATED","INTERVENTIONAL",[111],"NA","This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD\u002FNAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.",[114,115,116],"NASH","NAFLD","MAFLD",[114,116,115,118,119,120,121],"Probiotics","Resistance training","Gut microbiota","Hypertrophy training","NOT_YET_RECRUITING","2026-04-07",{"date":125,"type":126},"2026-04-09","ACTUAL",{"date":128,"type":108},"2026-04-10",{"date":130,"type":108},"2036-04-10",{"name":5,"class":6}]