Effect of a New Food Product on Weight Gain During First Infancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Changes in nutritional status
研究概览
简要总结
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
详细描述
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lactating babies
- •6 months of age
- •Informed consent signed by parents
排除标准
- •Malformations, diseases or conditions that may alter development and/or nutritional status
- •Born very and extremely preterm (<32 weeks of gestational age)
研究组 & 干预措施
New Infant Cereal
The amount of cereal administered will be free and from 6 to 12 months of age.
干预措施: New Infant Cereal (Dietary Supplement)
Standard Infant Cereal
The amount of cereal administered will be free and from 6 to 12 months of age.
干预措施: Standard Infant Cereal (Dietary Supplement)
结局指标
主要结局
Changes in nutritional status
时间窗: At 6, 9, 12, 15 and 18 months of age
Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).
次要结局
- Changes in intestinal microbiota(At 6, 9, 12 and 18 months of age)
- Changes in appetite(At 6, 9, 12, 15 and 18 months of age)
- Tolerability of study product(At 6, 9, 12, 15 and 18 months of age)