The Impact of Nutrition Education and Rice Bran Supplementation on Metabolic Dysfunction-associated Steatotic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
This study aims to evaluate the effects of nutrition education with or without rice bran supplementation in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants were recruited from the Division of Gastroenterology and Hepatology at Changhua Christian Hospital and assigned to either a nutrition education (NE) group or a nutrition education plus rice bran (NERB) group. The intervention was conducted for a specified study period, during which participants received dietary guidance and follow-up assessments.
The primary objective of this study is to determine whether rice bran supplementation in addition to nutrition education provides greater benefits on body weight, body mass index, dietary intake, and metabolic parameters compared with nutrition education alone. Secondary outcomes include changes in liver-related biochemical markers, glycemic indicators, lipid profiles, and other anthropometric measurements.
This study may provide evidence on the potential role of rice bran as a functional dietary supplement for improving metabolic health in patients with MASLD and may support the development of practical nutritional strategies for disease management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight or obese (BMI > 24 kg/m²)
- •diagnosed by a physician with moderate fatty liver (grade II)
排除标准
- •had stage 3 or higher chronic kidney disease
- •were undergoing treatment for malignant disease
- •had hepatitis B or hepatitis C infection or carrier status
- •had alcoholic hepatitis
- •had a known allergy to rice bran.
研究组 & 干预措施
NE Group
Participants in this arm received structured nutrition education during the study period.
干预措施: Nutrition Education (Behavioral)
NERB Group
Participants received structured nutrition education together with rice bran supplementation during the intervention period.
干预措施: Nutrition Education (Behavioral)
NERB Group
Participants received structured nutrition education together with rice bran supplementation during the intervention period.
干预措施: Rice Bran (Dietary Supplement)
结局指标
主要结局
Change in body weight
时间窗: From enrollment to the end of treatment at 3 months
Body weight was measured to evaluate the effect of nutrition education with or without rice bran supplementation.
次要结局
- Change in body mass index(From enrollment to the end of treatment at 3 months)
- Change in waist circumference(From enrollment to the end of treatment at 3 months)
- Change in body fat percentage(From enrollment to the end of treatment at 3 months)
- Change in visceral fat area(From enrollment to the end of treatment at 3 months)
- Change in energy intake(From enrollment to the end of treatment at 3 months)
- Change in dietary fiber intake(From enrollment to the end of treatment at 3 months)
- Change in fasting glucose(From enrollment to the end of treatment at 3 months)
- Change in HbA1c(From enrollment to the end of treatment at 3 months)
- Change in fasting insulin(From enrollment to the end of treatment at 3 months)
- Change in triglycerides(From enrollment to the end of treatment at 3 months)
- Change in HDL-cholesterol(From enrollment to the end of treatment at 3 months)
- Change in LDL-cholesterol(From enrollment to the end of treatment at 3 months)
- Change in alanine aminotransferase(From enrollment to the end of treatment at 3 months)
- Change in aspartate aminotransferase(From enrollment to the end of treatment at 3 months)
- Change in FibroScan liver stiffness measurement (E, kPa)(From enrollment to the end of treatment at 3 months)
- Change in FibroScan controlled attenuation parameter (CAP, dB/m)(From enrollment to the end of treatment at 3 months)