Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease

Khyber Medical University Peshawar

Status: Enrolling

Conditions: Neurocognitive Disorders; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Structured Mediterranean Diet; Behavioral: Control / General Advice

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07294963

KMU/DIR/CTU/2025/010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Mediterranean Diet Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Structured Mediterranean Diet

Control / General Advice

Active Comparator group

Description:

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).

Treatment:

Behavioral: Control / General Advice

Combined Diet and Exercise Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Control / General Advice

Behavioral: Structured Mediterranean Diet