Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorKhyber Medical University Peshawar
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
History of alcohol intake >20g/day.
Chronic viral hepatitis B or C.
Major neuropsychiatric illnesses.
Pregnancy or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Mediterranean Diet
BehavioralA 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
BehavioralThis 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Mediterranean Diet InterventionExperimental treatment 1 intervention
Group B: Control / General AdviceActive comparator 1 intervention
Group C: Combined Diet and Exercise InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Composite of Heart Failure Hospitalization or Cardiovascular Death
Time to first adjudicated event of either hospitalization for worsening heart failure or cardiovascular death. Events will be confirmed by a blinded Clinical Events Committee (CEC).
Time frame
From randomization up to study completion (maximum follow-up of 30 months).2
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered disease-specific questionnaire. The Overall Summary Score (OSS) aggregates the physical limitation, symptom frequency, quality of life, and social limitation domains. Scores range from 0 to 100, where higher scores indicate better health status. The outcome is the change in KCCQ-OSS from baseline.
Time frame
Baseline, Month 12.3
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The ratio of change in serum NT-proBNP level from baseline. NT-proBNP will be measured in pg/mL by a central laboratory using a standardized assay.
Time frame
Baseline, Month 6.4
All-cause Mortality
Time from randomization to death from any cause.
Time frame
From randomization up to study completion (maximum follow-up of 30 months).Sponsors and contacts
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Khyber Medical University Peshawar
Lead sponsor
Northwest General Hospital and Research centre
Collaborator
Khyber Teaching Hospital
Collaborator
Source ClinicalTrials.gov