Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease
1 other identifier
interventional
45
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2026
ExpectedDecember 19, 2025
December 1, 2025
7 months
December 8, 2025
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Composite of Heart Failure Hospitalization or Cardiovascular Death
Time to first adjudicated event of either hospitalization for worsening heart failure or cardiovascular death. Events will be confirmed by a blinded Clinical Events Committee (CEC).
From randomization up to study completion (maximum follow-up of 30 months).
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered disease-specific questionnaire. The Overall Summary Score (OSS) aggregates the physical limitation, symptom frequency, quality of life, and social limitation domains. Scores range from 0 to 100, where higher scores indicate better health status. The outcome is the change in KCCQ-OSS from baseline.
Baseline, Month 12.
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The ratio of change in serum NT-proBNP level from baseline. NT-proBNP will be measured in pg/mL by a central laboratory using a standardized assay.
Baseline, Month 6.
All-cause Mortality
Time from randomization to death from any cause.
From randomization up to study completion (maximum follow-up of 30 months).
Study Arms (3)
Mediterranean Diet Intervention
EXPERIMENTALParticipants 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).
Control / General Advice
ACTIVE COMPARATORParticipants 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).
Combined Diet and Exercise Intervention
EXPERIMENTALParticipants 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).
Interventions
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).
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
You may qualify if:
- Age 18 to 42 years.
- 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).
You may not qualify if:
- History of alcohol intake \>20g/day.
- Chronic viral hepatitis B or C.
- Major neuropsychiatric illnesses.
- Pregnancy or breastfeeding.
- Chronic illnesses including Diabetes Mellitus and thyroid dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwest General Hospital and Research centrecollaborator
- Khyber Medical University Peshawarlead
- Khyber Teaching Hospitalcollaborator
Study Sites (2)
Khyber Teaching Hospital
Peshawar, KPK, 25100, Pakistan
Northwest General Hospital
Peshawar, KPK, 25100, Pakistan
Related Publications (4)
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.
PMID: 33572481BACKGROUNDSemmler 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.
PMID: 34328248BACKGROUNDWhitehead 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.
PMID: 26092476BACKGROUNDIshiba 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.
PMID: 29744597BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Ayesha Qaiser, PhD Scholar
Khyber Medical University Peshawar
- PRINCIPAL INVESTIGATOR
Dr Inayat Shah, PhD
Institute of Basic Medical Sciences, Khyber Medical University
- PRINCIPAL INVESTIGATOR
Dr Arshad Hussain, PhD
Northwest General Hospital, Peshawar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors conducting the Montreal Cognitive Assessment (MoCA) and laboratory technicians performing biomarker analyses (ELISA for T-Tau, cytokines, hormones) will be blinded to group assignment. Participants and the interventionists (dietitians, physiotherapists) cannot be blinded due to the behavioral nature of the lifestyle interventions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 19, 2025
Study Start
October 1, 2025
Primary Completion
April 28, 2026
Study Completion (Estimated)
June 15, 2026
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will become available 9 months after the publication of the primary results and will be accessible for 5 years.
- Access Criteria
- Data access requests should be directed to the corresponding author (Dr. Ayesha Qaiser) and will be reviewed by the trial's steering committee. Requestors will need to provide a methodologically sound proposal and sign a data use/access agreement.
De-identified individual participant data that underlie the results reported in the primary publication (including demographic, clinical, laboratory, and cognitive assessment data) will be made available to qualified researchers upon reasonable request. The data will be shared to achieve the aims in the approved proposal, subject to a data use agreement.