Non-Alcoholic Fatty Liver Disease (NAFLD) is a prevalent liver condition characterized by hepatic steatosis in the absence of significant alcohol consumption. Insulin resistance plays a pivotal role in the pathogenesis of NAFLD, contributing to hepatic lipid accumulation and inflammation. Emerging evidence suggests that vitamin supplementation may improve insulin sensitivity and mitigate liver-related complications in individuals with NAFLD. This clinical trial aims to investigate the effects of vitamins that help insulin resistance and liver health in individuals with NAFLD.
Objectives:
- To assess the impact of vitamin supplementation on insulin sensitivity in individuals with NAFLD.
- To evaluate changes in liver fat content and markers of liver inflammation following vitamin supplementation.
- To investigate the safety and tolerability of vitamin supplementation in individuals with NAFLD.
Participants:
Eligible participants will include adult individuals aged 18-65 years diagnosed with NAFLD based on clinical and imaging criteria. Exclusion criteria will include significant alcohol consumption (>20 g/day for women and >30 g/day for men), other liver diseases, uncontrolled diabetes mellitus, pregnancy, and use of medications known to affect liver function or insulin sensitivity.
Intervention:
Participants in the intervention group will receive a daily oral dose of vitamin supplements containing vitamin D, vitamin E, vitamin C, B vitamins (thiamine, riboflavin, niacin, pyridoxine, biotin, cobalamin), and vitamin K. The placebo group will receive identical-looking placebo capsules containing inert substances. Compliance will be monitored through pill counts and participant self-reports.
Outcome Measures:
Primary Outcome Measures:
- Change in insulin sensitivity assessed through OGTT-derived indices (e.g., HOMA-IR, Matsuda index).
- Change in liver fat content measured via MRI or ultrasound imaging.
- Secondary Outcome Measures:
- Change in liver enzyme levels (ALT, AST).
- Change in markers of inflammation (CRP, TNF-α).
- Change in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides).
- Adverse events and tolerability of vitamin supplementation.
Statistical Analysis:
Statistical analysis will be conducted using appropriate parametric or non-parametric tests, depending on the distribution of data. The efficacy of vitamin supplementation will be assessed using intention-to-treat analysis. Subgroup analyses may be performed based on baseline characteristics (e.g., severity of NAFLD, insulin resistance status).
Conclusion:
This clinical trial aims to provide valuable insights into the potential benefits of supplements for insulin resistance and improving liver health in individuals with NAFLD. The findings of this study may have significant implications for the development of adjunctive therapies for NAFLD management and prevention.
