The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 1
- 主要终点
- change in blood protein levels following dietary intervention
研究概览
简要总结
This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.
详细描述
This research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 8-14 years
排除标准
- •Allergic of eggs
- •People who cannot continue to follow up the protocol
- •Having contra-indication i.e. problems with blood clotting
研究组 & 干预措施
Whole eggs (WE)
consume 10 additional eggs per week
干预措施: whole eggs (Dietary Supplement)
Egg substitute (ES)
consume the yolk-free egg substitute equivalent to 10 eggs per week
干预措施: yolk-free egg substitutes (Dietary Supplement)
Control group
Regular school meals
结局指标
主要结局
change in blood protein levels following dietary intervention
时间窗: week 0 (baseline), week 13 - 14, week 34 - 35
transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis
changes in blood biochemistries following dietary intervention
时间窗: week 0 (baseline), week 13 - 14, week 34 - 35
fasting blood sugar (mg/dl), cholesterol (mg/dl), triglyceride (mg/dl), HDL-Cholesterol (mg/dl), LDL-Cholesterol (mg/dl)
changes in height following the dietary intervention
时间窗: week 0 (baseline), week 13 - 14, week 34 - 35
height (cm), height for age (z-score) analysis
changes in body weight following the dietary intervention
时间窗: week 0 (baseline), week 13 - 14, week 34 - 35
weight (kg), weight for age (z-score) analysis
次要结局
- changes in microbioma and stool metabolites following dietary intervention(week 0 (baseline), week 13 - 14, week 34 - 35)
- changes in blood biochemistries following dietary intervention metabolite enzyme(week 0 (baseline), week 13 - 14, week 34 - 35)