Measurement of Glycogen Replenishment in Children After an Overnight Fast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen
研究概览
简要总结
It is not fully understood in children how much of hepatic and muscle glycogen is used during a night and how they are replenished after a breakfast. This study aims to analyze the glycogen metabolism before and after an overnight sleep as well as after a breakfast in children between 8 and 12 years old.
详细描述
The aim of the study is to investigate if liver and muscle glycogen stores are depleted in children after overnight fasting and to what extend the stores are replenished with the intake of small breakfast.
The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).
An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy girls and boys between 8 and 12 years of age
- •Clinically healthy body weight (5 to 85th rounded percentile from UK)
- •In good health as determined by health screening questionnaires
- •English proficiency as per investigator judgment
- •Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation
排除标准
- •Girls having menstruations
- •Any type of self-reported food allergies
- •Lactose intolerance
- •Claustrophobic
- •Diagnosis of Diabetes Mellitus
- •Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
- •Ongoing diseases or intake of any prescribed or over the counter drugs
- •Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
- •Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.
结局指标
主要结局
Incremental/decremental AUC0-240 of the concentration/time curve of hepatic glycogen
时间窗: 4 hours
To determine the effects of 1 and 2 servings of a small breakfast on hepatic glycogen stores; measured by NMR
次要结局
- Change of hepatic glycogen content over an overnight fast(12 hours)
- Change of muscle glycogen content over an overnight fast(12 hours)
- Incremental/decremental AUC0-240 of the concentration/time curve of muscle glycogen(4 hours)