Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- Infant weight gain
研究概览
简要总结
The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
详细描述
Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.
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
- 13 Weeks 至 15 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infant
- •Infant is aged 14 weeks (+/- 1 week)
- •Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks
排除标准
- •Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
- •Infant born with congenital disease or malformation affecting growth and/or development
- •Food allergy to any trial products (e.g. milk, soy)
结局指标
主要结局
Infant weight gain
时间窗: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Rate of weight gain (g/d)
次要结局
- Adiposity(Age 2 years (+/- 1 month))
- Height-for-age Z-score(Age 2 years (+/- 1 month))
- Fat mass(Age 2 years (+/- 1 month))
- Body mass index (BMI)-for-age Z-score(Age 2 years (+/- 1 month))