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

Sponsor
Khyber Medical University Peshawar
Study ID
NCT07294963
Status
Recruiting
Apply to this trial

Conditions

  • Neurocognitive Disorders
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Structured Mediterranean Diet — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Apr 28, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Composite of Heart Failure Hospitalization or Cardiovascular Death [ Time Frame: From randomization up to study completion (maximum follow-up of 30 months). ]

Central Contacts

Related Studies