Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 主要终点
- Baby weight gain
研究概览
简要总结
The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.
详细描述
Human milk is considered as the golden standard for infant formula. In human milk and infant formula lipids provide about 55% of energy for the infant and represent as such a major nutrient for the baby. The vast majority of the lipids in human milk is composed of triacylglycerols (98% of total lipids) and the remainder percent are phospholipids. Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to 26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are preferentially esterified at the 1 and 3 position. In infant formulas the major source of palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at the 2-position of the triacylgycerol.
The aim of this study is to assess the safety and efficacy of infant formula containing 40% and 50%, respectively, of palmitic acid in sn-2 position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy newborn infants
- •full term infant (37 - 42 weeks gestation)
- •birth weight between 2.5 and 4.5 kg
- •singleton birth
- •the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
- •having obtained his7her legal representative's informed consent
排除标准
- •congenital illness or malformation that may affect normal growth
- •significant pre-natal and/or post-natal disease
- •hospitalization in the first 14 days of life after the child has left the maternity ward
- •receiving antibiotic treatment at time of enrolment
- •newborn whose parents/caregivers cannot be expected to comply with treatment
- •newborn currently participating in another interventional clinical trial.
结局指标
主要结局
Baby weight gain
时间窗: 4 months
To demonstrate that the weight gain in babies receiving the experimental formula is the same as with the control formula
Stool consistency
时间窗: 4 months
To demonstrate that the infants receiving an infant formula with 40% or 50% of palmitic acid during the first 4 months of life have softer stools than the ones receiving the control formula.
次要结局
- Digestive tolerance using a questionnaire filled in by the mothers(4 months)
- Baby body composition (DEXA)(4 months)
- Food intake by the baby(4 months)
- Fat quantity in the stools(4 months)
- Rate of spitting up(4 months)
- Baby length and head circumference(4 months)
- Gut microbiota using microbiology method(4 months)
- Number of adverse events(4 months)