Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- metabolic response
研究概览
简要总结
In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy infants born
- •weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
- •age between 5 - 7th month of life at study entry
- •fully formula fed for at least 4 weeks before intervention start
- •parents/caregivers understand the German language and are able to fill out questionnaires
- •parents/caregivers agree to study participation and sign the informed consent form
排除标准
- •acute or chronic illness of infant or mother
- •drug and/or alcohol abuses of mother
- •chronic medication
- •participation of the infant in another intervention study
- •gestational diabetes of the mother
结局指标
主要结局
metabolic response
时间窗: After 4 week intervention period
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
次要结局
未报告次要终点
研究者
Koletzko - Office
Prof. Berthold Koletzko
Ludwig-Maximilians - University of Munich