Treating Pediatric NAFLD With Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in hepatic steatosis measured by liver MRI-PDFF
研究概览
简要总结
This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.
详细描述
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD.
This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 through 17 years
- •ALT of ≥ 40 U/L
- •MRI-PDFF ≥ 8%
- •Ability and willingness of legal guardian and participant to provide written, informed consent
排除标准
- •Competing Health Conditions
- •Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator
- •Type 1 or Type 2 Diabetes
- •LDL-cholesterol > 160 mg/dL
- •Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease)
- •History of bariatric surgery or planning to undergo bariatric surgery during the study duration
- •Participant with a history of conditions affecting digestion and/or absorption
- •Intervention
- •Inability or refusal to consume dairy
- •Cow's milk protein allergy
- •Lactose intolerance
结局指标
主要结局
Change in hepatic steatosis measured by liver MRI-PDFF
时间窗: Baseline to 12 weeks and 12 weeks to 24 weeks
The primary outcome for the 24 week study is to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD
次要结局
- Change in serum LDL-cholesterol(Baseline, week 12 and week 24)
- Change in serum HDL-cholesterol(Baseline, week 12 and week 24)
- Change in serum triglycerides(Baseline, week 12 and week 24)
- Change in serum alanine transaminase (ALT)(Baseline, week 12 and week 24)
- Change in serum aspartate transaminase (AST)(Baseline, week 12 and week 24)
- Change in serum gamma-glutamyl transpeptidase (GGT)(Baseline, week 12 and week 24)
- Change in serum total cholesterol(Baseline, week 12 and week 24)
- Change in plasma fatty acid levels(Baseline, week 12 and week 24)
- Change in subcutaneous adipose tissue (SCAT)(Baseline, week 12 and week 24)
- Change in visceral adipose tissue (VAT)(Baseline, week 12 and week 24)
研究者
Jeffrey B. Schwimmer, MD
Principal Investigator, Professor of Clinical Pediatrics
University of California, San Diego