[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615619":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":44,"locations":53,"responsibleParty":81,"collaborators":83,"id":88,"slug":30,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":30,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":30,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Mediterranean Diet Intervention","EXPERIMENTAL","Participants will follow a structured, culturally adapted Mediterranean diet plan for 6 months, designed and supervised by a qualified dietitian. The diet emphasizes whole grains, vegetables, fruits, legumes, nuts, olive oil, and lean proteins (detailed 7-day plan in Annexure 7). Support includes individualized counseling, provision of meal plans, weekly food diaries, 24-hour dietary recalls, and monthly check-ins. Outcome assessments occur at T0, T1 (6 months), and T2 (12 months).",[13],"Behavioral: Structured Mediterranean Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Control \u002F General Advice","ACTIVE_COMPARATOR","Participants will receive general verbal and written advice on healthy eating and physical activity, consistent with standard care. No structured diet plan or supervised exercise will be provided. They will undergo all outcome assessments (FibroScan, FIB-4, MoCA, biomarker blood draws) at Baseline (T0), 6 months (T1), and 12 months (T2).",[19],"Behavioral: Control \u002F General Advice",{"label":21,"type":10,"description":22,"interventionNames":23},"Combined Diet and Exercise Intervention","Participants will receive the identical Mediterranean diet intervention as Arm 2 plus a structured, progressive aerobic exercise program. The exercise consists of a 60-minute walking session, 5 days per week, for 6 months, progressing through conditioning, strength-building, and endurance phases (detailed in Annexure III). Compliance is monitored via exercise logs, fortnightly contact, and monthly check-ins. Outcome assessments occur at T0, T1 (6 months), and T2 (12 months).",[13,19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Structured Mediterranean Diet","A culturally adapted, structured dietary plan based on the Mediterranean diet principles, delivered through individual dietitian counseling, provision of weekly meal plans, and ongoing compliance support (food diaries, recalls, monthly check-ins).",[21,9],null,{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"This intervention consists of providing standardized, non-structured verbal and written information on the principles of a balanced diet and the benefits of regular physical activity, as per routine clinical practice. It serves as the active comparator representing minimal intervention.",[21,15],[35,38,41],{"name":36,"affiliation":5,"role":37},"Dr Ayesha Qaiser, PhD Scholar","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Dr Inayat Shah, PhD","Institute of Basic Medical Sciences, Khyber Medical University",{"name":42,"affiliation":43,"role":37},"Dr Arshad Hussain, PhD","Northwest General Hospital, Peshawar",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Dr Ayesha Qaiser, MBBS, PhD Scholar","CONTACT","+92 332 9135697","dr.ayeshaqaiser@hotmail.com",{"name":39,"role":47,"phone":51,"phoneExt":30,"email":52},"+92 332 1431414","inayat.shah@kmu.edu.pk",[54,73],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Khyber Teaching Hospital","RECRUITING","Peshawar","KPK","25100","Pakistan","PK",{"type":63,"coordinates":64},"Point",[65,66],71.57849,34.008,{"lat":66,"lon":65},[69,70],{"name":36,"role":47,"phone":30,"phoneExt":30,"email":49},{"name":42,"role":47,"phone":71,"phoneExt":30,"email":72},"03312710692","Hussainadr@gmail.com",{"facility":74,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Northwest General Hospital",{"type":63,"coordinates":76},[65,66],{"lat":66,"lon":65},[79,80],{"name":36,"role":47,"phone":48,"phoneExt":30,"email":49},{"name":39,"role":47,"phone":51,"phoneExt":30,"email":52},{"type":82,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[84,87],{"name":85,"class":86},"Northwest General Hospital and Research centre","NETWORK",{"name":55,"class":6},"100615619",false,"NCT07294963","Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease","Impact of Lifestyle Interventions on Cognitive Decline in NAFLD: A Randomized Controlled Trial of Liver Fibrosis, Hormonal Imbalance, and Inflammatory Markers","Inclusion Criteria:\n\n* Age 18 to 42 years.\n* Diagnosed with fatty liver (NAFLD) via imaging (e.g., ultrasound).\n* Liver fibrosis assessed and staged via FibroScan and the FIB-4 index.\n* Literate (to consent and complete cognitive assessments\u002Fquestionnaires).\n\nExclusion Criteria:\n\n* History of alcohol intake \\>20g\u002Fday.\n* Chronic viral hepatitis B or C.\n* Major neuropsychiatric illnesses.\n* Pregnancy or breastfeeding.\n* Chronic illnesses including Diabetes Mellitus and thyroid dysfunction.","ALL","18 Years","42 Years",{"count":98,"type":99},45,"ESTIMATED","INTERVENTIONAL",[102],"NA","This study investigates whether a structured lifestyle program can help improve thinking skills and liver health in adults with Non-Alcoholic Fatty Liver Disease (NAFLD). We are enrolling 45 participants, aged 18-42, who will be randomly assigned to one of three groups for six months: one receiving general health advice, a second following a supervised Mediterranean diet plan, and a third combining the same diet with a regular walking program. The main goal is to see if these diet and exercise interventions can lead to better scores on memory and reasoning tests, reduce liver stiffness measured by a painless scan (FibroScan), and improve related blood markers of inflammation and hormone balance.",[105,106],"Non-Alcoholic Fatty Liver Disease","Neurocognitive Disorders",[108,109,110,111,105],"Hepatocerebral Syndrome","Metabolic dysfunction-Associated SteatoHepatitis","Cognitive Decline","Liver Fibrosis","2025-12-08",{"date":114,"type":115},"2025-12-19","ACTUAL",{"date":117,"type":115},"2025-10-01",{"date":119,"type":99},"2026-06-15",{"name":5,"class":6},2]