Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in liver disease severity
研究概览
简要总结
A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
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
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with overweight/obesity
- •Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF >10%
- •Known NAFLD or elevated ALT for sex (>22 for females and >26 for males)
排除标准
- •MRI-PDFF <10%
- •Baseline habitual (>3 days per week) consumption of soy foods
- •Allergy to soy or cow's milk protein
- •Inability to undergo MRI
- •Recent (past 8 weeks) antibiotic exposure
- •Treatment for existing endocrine disorders
研究组 & 干预措施
2% Fat Cows Milk
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
干预措施: 2% Fat Cow's Milk (Drug)
Standard Soy Milk
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
干预措施: Standard Soy Milk (Drug)
结局指标
主要结局
Change in liver disease severity
时间窗: 12 weeks
Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.
次要结局
- Change in systolic and diastolic blood pressure(12 weeks)
- Change in fasting triglycerides(12 weeks)
- Change in gamma glutamyl-transferase levels (GGT)(12 weeks)
- Change in total cholesterol (TC)(12 weeks)
- Change in insulin(12 weeks)
- Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels(12 weeks)
- Change in alkaline phosphatase (ALP)(12 weeks)
- Change in serum metabolome and lipidome(12 weeks)
- Change in equol production status(12 weeks)
- Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])(12 weeks)
- Change in glucose(12 weeks)
- Change in glycated hemoglobin (HbA1c)(12 weeks)
- Change in thyroid function (TSH and Free T4)(12 weeks)
- Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels(12 weeks)
- Change in estradiol(12 weeks)
研究者
Marialena Mouzaki
Professor, Division of Gastroenterology, Hepatology and Nutrition
Children's Hospital Medical Center, Cincinnati