NCT06122272已完成不适用
An Exploratory, Randomised, Open Label, Controlled, Multicentre Clinical Trial in Hong Kong to Explore the Effect of a New Nutritional Formula on Body Composition and Other Health Outcomes in Early Life.
Danone Nutricia2 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2023年12月19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
- 180
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life.
详细描述
- Key exploratory objective is to find an effect on body composition.
- Other exploratory objectives are to find an effect on growth parameters.
- Safety and tolerance and the user experience will be investigated.
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
- None
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
- •Healthy, singleton, term born infants.
- •Infants aged 6 months(± 2 weeks) at enrolment.
- •Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
- •Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
排除标准
- •Infants who require a special diet other than Formula with intact cow's milk protein.
- •Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
- •Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- •Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
- •Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
- •Employees and/or infants/family members or relatives of employees of Danone Nutricia, the participating sites, or any other nutrition company that develops Infant, Follow On or Young Child formulae.
结局指标
主要结局
Body composition
时间窗: Every 6 months, up to 12 months
Fat mass (kg)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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