Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease
NCT ID: NCT07294963
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-10-01
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mediterranean Diet Intervention
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).
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).
Control / General Advice
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).
Control / General Advice
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.
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).
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).
Control / General Advice
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.
Interventions
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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).
Control / General Advice
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with fatty liver (NAFLD) via imaging (e.g., ultrasound).
* Liver fibrosis assessed and staged via FibroScan and the FIB-4 index.
* Literate (to consent and complete cognitive assessments/questionnaires).
Exclusion Criteria
* Chronic viral hepatitis B or C.
* Major neuropsychiatric illnesses.
* Pregnancy or breastfeeding.
* Chronic illnesses including Diabetes Mellitus and thyroid dysfunction.
18 Years
42 Years
ALL
No
Sponsors
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Northwest General Hospital and Research centre
NETWORK
Khyber Teaching Hospital
OTHER
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Dr Ayesha Qaiser, PhD Scholar
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical University Peshawar
Dr Inayat Shah, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Medical Sciences, Khyber Medical University
Dr Arshad Hussain, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwest General Hospital, Peshawar
Locations
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Khyber Teaching Hospital
Peshawar, KPK, Pakistan
Northwest General Hospital
Peshawar, KPK, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Dr Ayesha Qaiser, PhD Scholar
Role: primary
Dr Arshad Hussain, PhD
Role: backup
Dr Ayesha Qaiser, PhD Scholar
Role: primary
Dr Inayat Shah, PhD
Role: backup
References
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Kjaergaard K, Mikkelsen ACD, Wernberg CW, Gronkjaer LL, Eriksen PL, Damholdt MF, Mookerjee RP, Vilstrup H, Lauridsen MM, Thomsen KL. Cognitive Dysfunction in Non-Alcoholic Fatty Liver Disease-Current Knowledge, Mechanisms and Perspectives. J Clin Med. 2021 Feb 9;10(4):673. doi: 10.3390/jcm10040673.
Semmler G, Datz C, Reiberger T, Trauner M. Diet and exercise in NAFLD/NASH: Beyond the obvious. Liver Int. 2021 Oct;41(10):2249-2268. doi: 10.1111/liv.15024. Epub 2021 Aug 21.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Ishiba H, Sumida Y, Tanaka S, Yoneda M, Hyogo H, Ono M, Fujii H, Eguchi Y, Suzuki Y, Yoneda M, Takahashi H, Nakahara T, Seko Y, Mori K, Kanemasa K, Shimada K, Imai S, Imajo K, Kawaguchi T, Nakajima A, Chayama K, Saibara T, Shima T, Fujimoto K, Okanoue T, Itoh Y; Japan Study Group of Non-Alcoholic Fatty Liver Disease (JSG-NAFLD). The novel cutoff points for the FIB4 index categorized by age increase the diagnostic accuracy in NAFLD: a multi-center study. J Gastroenterol. 2018 Nov;53(11):1216-1224. doi: 10.1007/s00535-018-1474-y. Epub 2018 May 9.
Other Identifiers
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KMU/DIR/CTU/2025/010
Identifier Type: -
Identifier Source: org_study_id