Lifestyle program to improve thinking and liver health in adults with fatty liver (NAFLD)
Impact of Lifestyle Interventions on Cognitive Decline in NAFLD: A Randomized Controlled Trial of Liver Fibrosis, Hormonal Imbalance, and Inflammatory Markers
This study will test whether a structured Mediterranean diet, with or without a supervised walking program, can improve thinking skills and liver health in adults aged 18–42 with NAFLD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 2 sites (Peshawar, KPK and 1 other locations) |
| Trial ID | NCT07294963 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-group trial enrolling 45 adults with imaging-confirmed NAFLD who are 18–42 years old. Participants are randomly assigned 1:1:1 to receive general health advice, a structured Mediterranean diet, or the same diet plus a supervised walking program for six months. Primary outcomes are cognitive performance (MoCA) and serum T-Tau levels measured at baseline and 6 months; secondary outcomes include liver stiffness by FibroScan, FIB-4, inflammatory markers (IL-6, TNF-α) and hormonal profiles (cortisol, testosterone, estradiol). Analysis will follow intention-to-treat principles using repeated-measures ANOVA and regression models to explore intervention effects and biomarker correlations.
Who should consider this trial
Good fit: Ideal candidates are literate adults aged 18–42 with imaging-confirmed NAFLD who are willing to attend regular in-person visits and do not have diabetes, chronic viral hepatitis, significant alcohol use, major psychiatric illness, pregnancy, or thyroid dysfunction.
Not a fit: Patients with diabetes, chronic viral hepatitis, heavy alcohol intake, thyroid disease, pregnancy or breastfeeding, or major neuropsychiatric disorders are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the interventions could improve memory and reasoning while reducing liver stiffness and inflammation, possibly slowing disease progression.
How similar studies have performed: Prior lifestyle studies have shown that Mediterranean diets and exercise can reduce liver fat and improve metabolic markers and have suggested modest cognitive benefits, but combining diet plus supervised walking with T-Tau and MoCA outcomes in NAFLD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Peshawar, KPK and 1 other locations
- Khyber Teaching Hospital — Peshawar, Kpk, Pakistan (Recruiting)
- Northwest General Hospital — Peshawar, Kpk, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Ayesha Qaiser, PhD Scholar — Khyber Medical University Peshawar
- Study coordinator: Dr Ayesha Qaiser, MBBS, PhD Scholar
- Email: dr.ayeshaqaiser@hotmail.com
- Phone: +92 332 9135697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.