The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Satisfaction of the participants and their point of view on the experience
研究概览
简要总结
The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy
详细描述
- Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation:
Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study 2. Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function 3. Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 to 18 years
- •BMI percentile > 85th for age and sex
- •Diagnosis of hepatic steatosis on imaging (ultrasound or MR).
- •Diagnosis of hepatic steatosis, NASH, or fibrosis on liver biopsy.
- •Elevated alanine aminotransferase (ALT) enzyme level.
- •Index of hepatic steatosis 8xALT/AST + BMI (+2 for girls) > 30.
排除标准
- •Known chronic systematic diseases
- •Any other serious conditions which, according to the doctor's judgment, would prevent compliance and safe participation in the study until completion.
- •Exclusion criteria to be validated when contacting the participants and their parents/tutors:
- •Being pregnant.
- •Taking all kinds of prescription or over-the-counter natural health products/natural supplements/vitamins on an ongoing basis or within the next four months, excluding vitamin D.
- •Weight loss of 5% to 10% of the usual weight in the last six months before recruitment or weight change of 5% in the last three months.
- •Alcohol consumption > two drinks/day or > one day/week.
- •Known peanut allergy and/or to the medicinal ingredients contained in the active polyphenol supplement: elderberry, haskap, black chokeberry, blueberry, blackcurrant.
- •Any contraindications for MRI.
结局指标
主要结局
Satisfaction of the participants and their point of view on the experience
时间窗: Through study completion an average of 1 year
Percentage of satisfaction of participants enrolled
Retention:
时间窗: Through study completion an average of 1 year
The percentage of adolescents who agree to participate in the study and the retention
Compliance with polyphenol supplementation
时间窗: Through study completion an average of 1 year
Percentage of compliance
Adverse event
时间窗: Through study completion an average of 1 year
Percentage of adverse events
Recruitment
时间窗: Through study completion an average of 1 year
Rate of recruitment
Effectiveness of the data collection procedure during the visits
时间窗: Through study completion an average of 1 year
Percentage of completed visits
Sample size calculation for a randomized controlled study
时间窗: Through study completion an average of 1 year
A sample size for a future randomized controlled study will be calculated from the estimates obtained during this pilot study.
次要结局
- Change in hepatic steatosis MR(At recruitment, after 60 days, and after 120 days)
- Stool test(At recruitment, after 60 days, and after 120 days)
- Change in hepatic steatosis B-mode US(At recruitment, after 60 days, and after 120 days)
- Inflammatory marker 2(At recruitment, after 60 days, and after 120 days)
- Lipid markers 1(At recruitment, after 60 days, and after 120 days)
- Lipid markers 3(At recruitment, after 60 days, and after 120 days)
- Cholesterol(At recruitment, after 60 days, and after 120 days)
- Anthropometric measure(At recruitment, after 60 days, and after 120 days)
- Lipid markers 6(At recruitment, after 60 days, and after 120 days)
- Change in intima media thickness (vascular compliance)(At recruitment, after 60 days, and after 120 days)
- Metabolic syndrome(At recruitment, after 60 days, and after 120 days)
- Inflammatory marker 3(At recruitment, after 60 days, and after 120 days)
- Lipid markers 4(At recruitment, after 60 days, and after 120 days)
- Liver function test(At recruitment, after 60 days, and after 120 days)
- Inflammatory marker 1(At recruitment, after 60 days, and after 120 days)
- Lipid markers 2(At recruitment, after 60 days, and after 120 days)
- Lipid markers 5(At recruitment, after 60 days, and after 120 days)
研究者
Ramy El Jalbout
Assistant professor
St. Justine's Hospital