NCT02776592已完成不适用
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Mead Johnson Nutrition1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2016年7月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Change in Working Memory Capacity
研究概览
简要总结
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
详细描述
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health child, 4-5 years of age
- •Born as full-term (Gestational age of 37-42 weeks)
- •Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit
- •Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics
- •Signed informed consent
排除标准
- •History or known or suspected cow milk protein intolerance
- •Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit
- •Serious concurrent illness that will interfere in the general management of the child
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- •Child's z-score of weight for height at baseline is < -3 according to WHO criteria
结局指标
主要结局
Change in Working Memory Capacity
时间窗: Up to 24 weeks
Recall of variable sequences
次要结局
- Change in Motor Response Speeds(Up to 24 weeks)
- Stool Consistency Assessment(24 weeks)
- Height(24 weeks)
- Metabolite Biomarkers(Up to 24 weeks)
- Blood Fatty Acids(Up to 24 weeks)
- Change in Mental Response Speeds(Up to 24 weeks)
- Change in Manipulation of Visual Information(Up to 24 weeks)
- Change in Retention of Visual Information(Up to 24 weeks)
- Change in Child Behavior Checklist(Up to 24 weeks)
- Immune Markers(Up to 24 weeks)
- Systemic antibiotic Usage(24 weeks)
- Missed days due to illness(24 weeks)
- Body Weight(24 weeks)
- Study Product Intake Assessment(24 weeks)
- Complete Blood Count (CBC)(Up to 24 weeks)
- Serum Phospholipids(Up to 24 weeks)
- Medically-confirmed adverse events(24 weeks)
研究者
研究点 (1)
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