Impact of Lifestyle Interventions on Cognitive Decline in NAFLD: A Randomized Controlled Trial of Liver Fibrosis, Hormonal Imbalance, and Inflammatory Markers
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Pakistan
Khyber Teaching Hospital
RECRUITING
Peshawar
Northwest General Hospital
RECRUITING
Peshawar
Contact Information
Primary
Dr Ayesha Qaiser, MBBS, PhD Scholar
dr.ayeshaqaiser@hotmail.com
+92 332 9135697
Backup
Dr Inayat Shah, PhD
inayat.shah@kmu.edu.pk
+92 332 1431414
Time Frame
Start Date:2025-10-01
Estimated Completion Date:2026-06-15
Participants
Target number of participants:45
Treatments
Experimental: 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).
Active_comparator: 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).
Experimental: 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).