The Effects of Plant Stanol Ester Supplements on Liver Inflammation in Overweight and Obese Children
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in plasma ALT concentration at 6 and 12 months.
研究概览
简要总结
Obesity is associated with a variety of co-morbidities. Children with obesity are more likely to have risk factors associated with cardiovascular diseases (CVD) and CVD risk markers (e.g. hypertension, elevated serum cholesterol, and type 2 diabetes mellitus), but also with organ specific pathologies such as a non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is approximately 35%, compared to approximately 8% in general pediatric population, making it a very important health threat in these populations. Successful pharmacological interventions to treat or prevent NASH are not yet available and so far only weight loss has clear benefits. However, it is well known that sustained weight-loss is difficult to achieve on the longer-term. The investigators recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. Moreover, Javanmardi et al. recently demonstrated in a population of adult NAFLD patients, that plasma concentrations of Alanine Transaminase (ALT) were reduced after daily plant sterol consumption (1.6 g/d) for 6 weeks. In this study, the investigators propose to evaluate the effect of consuming soft chews enriched with plant stanol esters (3 grams/day) on ALT concentrations in children with overweight or (morbid) obesity who are at risk of developing NAFLD, in a randomized, placebo-controlled, double blinded study with an intervention period and follow-up period of 6 months. 52 overweight and obese children with elevated ALT concentrations (>39 U/L for boys and >33 U/L for girls) will be included. All children will be randomly allocated to consume control or plant stanol ester enriched soft chews on a daily basis for a period of 6 months. After 12 months there will be an additional blood sample to evaluate whether the 6 months intervention is still effective.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in lifestyle intervention, provided by the Centre for Overweight Adolescent and Children Healthcare (COACH), at the Department of Pediatrics at the Maastricht University Medical Center (MUMC+).
- •Age between 4-18 years old
- •Plasma ALT concentrations above 39 U/L for boys and above 33 U/L for girls.
- •Willingness to consume 6 soft chews on a daily basis, for a period of 6 months.
排除标准
- •Presence of a severe medical condition, which contraindicates, in the investigators judgement, entry to the study.
- •No signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older).
结局指标
主要结局
Change in plasma ALT concentration at 6 and 12 months.
时间窗: Baseline, 6 months and 12 months
Plasma ALT (Alanine Aminotransferase) concentration is a laboratory parameter, measured in blood, reflecting possible presence of NAFLD. Concentrations below 26 U/L for boys, and below 22 U/L for girls, are considered normal. Concentrations above 39 U/L for boys, and above 33 U/L are considered to reflect presence of NAFLD.
次要结局
- Change in ultrasonographic hepatorenal index (HRI) at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in continuous Controlled Attenuation Parameter (CAP) at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in plasma AST and plasma CK-18 concentration at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in lipid metabolism parameters at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in plasma insulin concentration at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in non-cholesterol sterol and oxy(phyto)sterol concentrations at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in insulin sensitivity at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in liver inflammation parameters at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in lipid protein metabolism parameters at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in plasma inflammatory markers at 6 and 12 months.(Baseline, 6 months and 12 months)
- Change in plasma glucose concentration at 6 and 12 months.(Baseline, 6 months and 12 months)