Neurocognitive Disorders, Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Hepatocerebral Syndrome, Metabolic dysfunction-Associated SteatoHepatitis, Cognitive Decline, Liver Fibrosis, Non-Alcoholic Fatty Liver Disease
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.
Detailed description
This is a parallel-group, randomized controlled trial designed to evaluate the impact of lifestyle interventions on cognitive function in patients with NAFLD, and to explore associations with liver fibrosis severity and underlying biomarkers. The study aims to recruit 45 participants with imaging-confirmed NAFLD, who will be randomized (1:1:1) into a control group (general advice), a dietary intervention group (structured Mediterranean diet), or a combined intervention group (diet plus supervised exercise). Primary outcomes include cognitive performance measured by the Montreal Cognitive Assessment (MoCA) and serum T-Tau levels, assessed at baseline and after the 6-month intervention. Key secondary outcomes encompass changes in liver fibrosis (via FibroScan and FIB-4 index), inflammatory biomarkers (IL-6, TNF-α), and hormonal profiles (cortisol, testosterone, estradiol). The protocol has received ethical approval from the Khyber Medical University Institutional Review Board, and analysis will follow intention-to-treat principles using repeated-measures ANOVA and regression models to determine intervention efficacy and pathophysiological correlations.
Interventions
BEHAVIORALStructured 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).
BEHAVIORALControl / 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.
Sponsors
Khyber Medical University Peshawar
Northwest General Hospital and Research centre
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
A three-arm parallel-group randomized controlled trial will be conducted. Participants will be assigned to the Mediterranean Diet intervention, Control (general advice 2), and combined Mediterranean Diet + Structured Exercise intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Heart Failure Hospitalization or Cardiovascular Death | From randomization up to study completion (maximum follow-up of 30 months). | 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). |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline, Month 12. | 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. |
| Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) | Baseline, Month 6. | 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. |
| All-cause Mortality | From randomization up to study completion (maximum follow-up of 30 months). | Time from randomization to death from any cause. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr Ayesha Qaiser, PhD Scholar
Khyber Medical University Peshawar
PRINCIPAL_INVESTIGATORDr Inayat Shah, PhD
Institute of Basic Medical Sciences, Khyber Medical University
PRINCIPAL_INVESTIGATORDr Arshad Hussain, PhD
Northwest General Hospital, Peshawar
Outcome results
None listed