Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease (NCT07294963) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease
Pakistan45 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 42 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of Heart Failure Hospitalization or Cardiovascular Death
Timeframe: From randomization up to study completion (maximum follow-up of 30 months).
2
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Timeframe: Baseline, Month 12.
3
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Timeframe: Baseline, Month 6.
4
All-cause Mortality
Timeframe: From randomization up to study completion (maximum follow-up of 30 months).