Overview

Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity

Status:
Completed
Trial end date:
2022-01-21
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to investigate the effects of tocotrienol-rich fraction vitamin E supplementation on liver enzymes in overweight and obese children with non-alcoholic fatty liver disease as compared to placebo. The main question[s] it aims to answer are: 1. Does supplementation of tocotrienol-rich fraction vitamin E reduce the level of liver enzymes and improve liver steatosis in non-alcoholic fatty liver disease among overweight and obese children? 2. Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage? Participants will : 1. consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months. 2. Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid. 3. The following investigations were performed upon recruitment and following 6 months of intervention: (i) liver biomarker and enzymes; (ii) DNA damage; (iii) TNFα, IL-6 and IFN-gamma genes; (iv) Fibroscan.
Phase:
Phase 4
Details
Lead Sponsor:
National University of Malaysia
Treatments:
Tocopherols
Tocotrienols
Vitamin E