Effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic Fatty Liver Disease (NAFLD)

Category Primary study
Registry of TrialsSLCTR
Year 2015
INTERVENTION: 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 criteria will be randomized into two arms of 34 participants each. Subjects in the group A will receive capsules containing the interventional agent [delta‐tocotrienol 300mg (Riverside Pharmaceuticals, USA)] Subjects in the group B will receive a matching capsule containing sucrose 50mg as placebo. The capsules will be given in sealed envelopes. Subjects will be instructed to consume the contents of the envelopes twice daily for 24 weeks. CONDITION: Nonalcoholic fatty liver disease (NAFLD) PRIMARY OUTCOME: 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); SECONDARY OUTCOME: 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 ; 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
Epistemonikos ID: 2c469e1a11a553bdd4ac7382a63dce629e89e0e0
First added on: Aug 23, 2024