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

NCT07294963 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Neurocognitive Disorders

Interventions

BEHAVIORAL

Structured 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).

BEHAVIORAL

Control / 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 & Collaborators

  • Northwest General Hospital and Research centre

    collaborator NETWORK
  • Khyber Teaching Hospital

    collaborator OTHER
  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Dr Ayesha Qaiser, PhD Scholar · Khyber Medical University Peshawar

  • Dr Inayat Shah, PhD · Institute of Basic Medical Sciences, Khyber Medical University

  • Dr Arshad Hussain, PhD · Northwest General Hospital, Peshawar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-04-28
Completion
2026-06-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07294963 on ClinicalTrials.gov