[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573701":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Treatment Group","ACTIVE_COMPARATOR","The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 20 Kcal\u002FKg BW\u002Fday, with a protein intake of 0.9 gm\u002FKg BW\u002Fday i.e., around 15 % of total calories from protein, 25% from fats and 60% from carbohydrates.\n\nPhysical activity recommendations: Brisk walking on a treadmill (at a speed 5-6 Kmph for 60 minutes) OR 5000 steps per day by pedometer counting.",[13],"Dietary Supplement: Normal Protein diet",{"label":15,"type":16,"description":17,"interventionNames":18},"High Protein Diet","EXPERIMENTAL","The intervention is planned as a supervised dietary supplementation, with a goal of restricting the calorie intake to 20 Kcal\u002FKg BW\u002Fday, with a protein intake of 1.3 gm\u002FKg BW\u002Fday i.e., around 25 % of total calories from protein, 25% from fats and 50% from carbohydrates. Major portion of the protein would be met by dairy, legumes and pulses along with egg whites.\n\nPhysical activity recommendations: Brisk walking on a treadmill (at a speed 5-6 Kmph for 60 minutes) OR 5000 steps per day by pedometer counting.",[19],"Dietary Supplement: High protein diet",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","High protein diet",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Normal Protein diet","Normal protein diet",[9],[31],{"name":32,"affiliation":33,"role":34},"Jaya Benjamin, PhD","Institute of Liver and Biliary Sciences","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Kanika Jain, MSc","CONTACT","08076030183","kanikjain@gmail.com",[42],{"facility":33,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Delhi","New Delhi","110070","India","IN",{"type":49,"coordinates":50},"Point",[51,52],77.23149,28.65195,{"lat":52,"lon":51},[55,59],{"name":56,"role":38,"phone":57,"phoneExt":25,"email":58},"Jaya Benjamin, Dr","9540951081","jayabenjaminilbs@gmail.com",{"name":37,"role":38,"phone":60,"phoneExt":25,"email":40},"8076030183",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100573701","effect-of-high-protein-diet-on-hepatic-steatosis-in-patients-with-mafld-100573701",false,"NCT06749704","Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD","Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP \\>250, BMI\\>23 and\u002For DM) Age 18-65 years\n\nExclusion Criteria:\n\n* • Lean (BMI \\\u003C23) patients\n\n  * Age \\\u003C18 and \\>65 years\n  * Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months\n  * Patients with viral hepatitis\n  * Patients with significant alcohol consumption (regular consumption of \\> 10g per day for females and \\> 20g\u002Fd in males),\n  * Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded\n  * Pregnant \\& lactating women","ALL","18 Years","60 Years",{"count":74,"type":75},140,"ESTIMATED","INTERVENTIONAL",[78],"NA","MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.",[81],"Metabolic Dysfunction Associated Fatty Liver Disease",[83,84,85],"mitochondrial dysfunction","metabolic inflexibility","FGF21 resistance","NOT_YET_RECRUITING","2024-12-24",{"date":89,"type":90},"2024-12-27","ACTUAL",{"date":89,"type":75},{"date":93,"type":75},"2027-05-01",{"name":5,"class":6},1]