Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Alanine Transaminase (ALT)
研究概览
简要总结
In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions:
- Standard of care
- Water delivery
- Water with Rebaudioside (stevia natural sweetener)
详细描述
Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.
Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:
- Standard of Care
- Water Delivery
- Water with Rebaudioside (Stevia Natural Sweetener)
Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 10-18 years
- •ALT > 45 IU/L (twice the normal amount)
- •BMI >85%
- •Fat >5% and kPa> 2.7
排除标准
- •Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.
- •Familial hyperlipidemia
- •Positive hepatitis lab
- •Antibiotics within 1 month of beginning the study
- •Physical, mental, or cognitive issues preventing participation
- •Pregnancy
- •Smoking or drinking
研究组 & 干预措施
Standard of Care
The control group will receive standard of care dietary advice for their solid food and beverage intake.
Water Intervention
We will order and deliver bottled water to the homes of subjects in the treatment group. We will provide each participant with a weekly supply of about 36 16.9 fl oz single-serving containers. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously.
干预措施: Water Intervention (Other)
Stevia Intervention
We will order and deliver a commercially-available stevia-sweetened soft drink Zevia (Los Angeles, CA) to each participant in the treatment group. We will provide each participant with a weekly supply of 24 12 fl oz single-serving containers. Zevia will be provided in an assortment of flavors for the first week, then catered to the preference of the participant for the remainder of the study. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. Participants will also be asked to keep track of how many containers they consume using a sticker chart, and we will also phone parents weekly to verify the sticker charts
干预措施: Stevia Intervention (Other)
结局指标
主要结局
Change in Alanine Transaminase (ALT)
时间窗: Week 1 to week 8 (IU/L)
A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups
次要结局
- Change in Weight(week 1 to 8 weeks (kg))
- Change in Triglyceride levels(week 1 to 8 weeks)
- Change in Fat percentage(week 1 to 8 weeks (%))
- Change in Waist Circumference(week 1 to 8 weeks (cm))
- Change in kPA levels(week 1 to 8 weeks (kPA))
- Change in Height(week 1 to 8 weeks (cm))
- Change in Acanthosis nigricans skin exam(week 1 to 8 weeks)
- Change in Glucose Level(Week 1 to week 8 (mg/dl))
- Change in Insulin Level(Week 1 to week 8 (UIU/mL))
研究者
Tania Mitsinikos
Medical Staff/USC Faculty CWR
Children's Hospital Los Angeles