Nonalcoholic fatty liver disease (NAFLD)
Conditions
Interventions
The interventional product is Delta-tocotrienol, a natural Vitamin E compound that is available in the market as a dietary supplement.
Consenting participants fulfilling the inclusion/exclusion crite
Sponsors
Armed Forces Institute of Pathology, Pakistan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both genders aged 20 years and above. 2. Ultrasound-proven fatty liver 3. Fatty Liver Index (FLI) score of equal to or more than 60 4. Mild to moderate elevation of alanine transaminase (ALT) and aspartate transaminase (AST) i.e. not greater than four times the upper limit of 42 IU/L and 37 IU/L respectively
Exclusion criteria
Exclusion criteria: 1. Chronic hepatitis B and C 2. Alcoholic fatty liver disease 3. Any other acute or chronic illness including cancer 4. Autoimmune liver disease 5. Patients receiving other medications including herbal or vitamin supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 40% reduction in Fatty Liver index (FLI) score from the baseline value 2. 25% reduction in insulin resistance (IR) calculated by Homeostasis Model Assessment (HOMA) [At baseline,12 weeks and 24 weeks (end of trial)] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 40% reduction in High-sensitivity C-reactive protein (hs-CRP), Malondialdehyde (MDA), Alanine transaminase (ALT) and Aspartate transaminase (AST) from the baseline values 2. Grading of NAFLD on ultrasonography [At baseline,12 weeks and 24 weeks(end of trial)] | — |
Countries
Pakistan
Contacts
Public ContactProfessor Dilshad Ahmed Khan
Professor of Pathology
Outcome results
None listed