Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Analysis of IGF-1 value
研究概览
简要总结
A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.
详细描述
The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% lower to the IGF-1 measured in infants that received a high protein content formula (HiF).
The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass (LM); the metabolomics and aminogramm during the first year of life.
Subjects are included in the study for a duration of 5 years. From birth to 4 months they are exclusively fed BF or FF. From 4 months of age they can start diversification, but they maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are then followed up until 5 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •. Healthy newborn infant
- •Full term infant (= 37 weeks gestation; = 42 weeks gestation)
- •Birth weight = 2500 g and < 4200 g
- •Singleton birth
- •Infant is = 7 days of age at the time of enrollment
- •For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
- •Having obtained his/her or his/her legal representative's consent
排除标准
- •Newborn whose mother's BMI was normal (<20 or = 25) at start of pregnancy
- •Newborn whose mother had developed gestational diabetes during pregnancy
- •Newborn whose mother has diabetes of type-1 or type-2
- •Newborn whose mother smoked > 5 cigarettes / day during pregnancy
- •Newborn whose mother had a drug dependence during pregnancy
- •Newborn whose mother has a chronic infectious disease
- •Newborn whose parents / caregivers cannot be expected to comply with treatment
- •Newborn currently participating in another clinical trial
研究组 & 干预措施
Group Breastfeeding
Breastfeeding
Group 1: Low protein formula
Low protein formula
干预措施: Low protein formula (Other)
Group 2: high protein formula
High protein formula
干预措施: High protein formula (Other)
结局指标
主要结局
Analysis of IGF-1 value
时间窗: 4 months
Analyse the IGF-1 value and compare it
次要结局
- DEXA scan as a measure of the body composition(2 weeks, 4 months and 12 months)
- Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1)(2 weeks, 4 months and 12 months)
- aminogramm analysis(2 weeks, 4 months and 12 months)