A Follow-up Study of a Randomised, Controlled, Study to Investigate the Effects of a New Infant Formula Given in the First 12 Months of Life on Growth and Body Composition up to 5 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age
详细描述
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age. Participants from Venus study will be invited to participate in this follow-up study.
Hypothesis
Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
- •Written informed consent from parent(s) or legally acceptable representatives
排除标准
- •Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements
结局指标
主要结局
Body Mass Index (BMI)
时间窗: up to 5 years of age
次要结局
- Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)(up to 5 years of age)
- Z-scores of Weight-for-age(up to 5 years of age)
- Z-scores of Weight-for-height(up to 5 years of age)
- Z-scores of BMI-for-age(up to 5 years of age)
- Z-scores of Height-for-age(up to 5 years of age)
- Z-score of Head circumference-for-age(up to 5 years of age)
- Z-score of Skinfold-for-age (subscapular, triceps)(up to 5 years of age)
- Z-score of Mid-upper-arm-circumference-for-age(up to 5 years of age)