Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity
Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity
NCT ID: NCT05905185 Phase: PHASE4 Status: COMPLETED Enrollment: 29 Completion: 2022-01-21
Conditions
Obesity
Interventions
Tocotrienol-rich fraction vitamin E (TRF), Placebo
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:
- 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?
- Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage?
Participants will :
- consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months.
- Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid.
- 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.
Primary Outcome
Mean difference of fibrosis score, inflammation (activity) score and steatosis score