NCT05576870招募中不适用
Growth Study Using a Toddler Almond Based Nutritional Drink (Test) vs. a. Formula That Has Been Shown to Support Growth (Control) in Healthy Toddlers
Else Nutrition GH Ltd2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- height velocity
研究概览
简要总结
The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers
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
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days,
- •Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
- •Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions)
- •Consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day
排除标准
- •Toddler with any positive food allergy test food allergy or intolerance to any foods
- •Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study
结局指标
主要结局
height velocity
时间窗: 4 months
Weight gain
时间窗: 4 months
次要结局
- Daily intake(4 months)
研究者
研究点 (2)
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