NCT04073407终止不适用
A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Number of Subjects With Adverse Events (AEs).
研究概览
简要总结
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and provide written informed consent.
- •Male and female adolescent subjects aged 12 to 17 years
- •Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 30 days prior to Screening.
- •Non alcoholic fatty liver disease
- •Diabetes or prediabetes
- •A screening MRI consistent with liver inflammation and fibrosis
排除标准
- •Current or history of significant alcohol consumption
- •History or presence of liver disease (other than NAFLD/NASH)
- •History or presence of cirrhosis and/or history or presence of hepatic decompensation
- •Any diabetes other than Type 2
- •Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg)
- •Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.),
- •Unable or unwilling to adhere to contraception requirements
- •Any contraindications to a MRI scan
- •Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo 24g
干预措施: Placebo (Dietary Supplement)
AXA1957
Active Comparator
AXA1957 20.4g
干预措施: AXA1957 (Dietary Supplement)
结局指标
主要结局
Number of Subjects With Adverse Events (AEs).
时间窗: AEs Baseline to week 13 - Part 1
Study food product emergent adverse events (AEs). Subjects reporting \>or equal to 1 study food product-emergent AE.
次要结局
未报告次要终点
研究者
研究点 (4)
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