NCT02441296已完成不适用
Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Glucose levels
研究概览
简要总结
The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined.
In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants (gestational age 37-42 weeks)
- •Birth weight 2500-4500g
排除标准
- •Infant illness
- •Maternal diabetes
- •Maternal pregnancy complications
结局指标
主要结局
Glucose levels
时间窗: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
The change in serum glucose levels are monitored following a test meal from baseline to 15 min, 30 min, 60 min, 90 min and 120 minutes
次要结局
- Insulin levels(2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min))
- Metabolite levels(2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min))
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