A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- SAM/SAH ratio
研究概览
简要总结
The purpose of this trial is to better define how individuals with different genetic make-ups will require different interventions to improve their methylation potential and nutrient status.
详细描述
Despite the increasing incidence of overweight and obesity among children, nutritional deficiencies are still a concern.
A low intake of vitamins and minerals is associated with a reduction in the antioxidant capacity. Some vitamins are associated with chronic diseases including overweight and obesity.
S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are the substrate and product of essential reactions; the SAM:SAH ratio has been associated with health and is an indicator of cellular DNA methylation potential.
Low level of this ratio may affect short and long term health. In this explorative knowledge building open interventional study, subject to be enrolled are children or adolescents 9 to 13 years of age per year (n=180 per year, over 2 years). The study consists of 6 weeks nutritional intervention followed by a 6 weeks follow up.
In this study, genomics, proteomics, lipidomics analysis will be performed, in addition to biochemistry, hematology and vitamins analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children or adolescents 9 to 13 years of age.
- •Clinically stable.
- •Normal weight, overweight and obese.
排除标准
- •Disease diagnosis.
- •At least one episode of axillary temperature >37°C over the prior 15 days.
- •Three or more episodes of liquid or semi-liquid stools over the prior 24 hours.
- •Supplementation with vitamins and/or minerals.
- •On a supervised diet for reducing weight or any other type of diet restriction.
- •Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
结局指标
主要结局
SAM/SAH ratio
时间窗: baseline and after 6 weeks of product intake
Change from baseline in the correlation between the SAM/SAH ratio in erythrocytes, dietary intakes and, polymorphisms in genes associated with micronutrients
次要结局
- SNP arrays, proteomics, metabolomics, micronutrient levels(baseline, after 6 weeks of product intake and after 6 weeks of follow up)
- SAM/SAH ratio(after 6 weeks product intake and after 6 weeks of follow up)