The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intestinal flora composition
研究概览
简要总结
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.
详细描述
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental/ legal guardian written inform consent
- •The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
- •Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- •Birth weight appropriate for gestational age (AGA).
- •The infant is apparently healthy at birth and entry to study.
- •Apgar after 5 minutes >7
- •Enrolled within their first 7 days of life
- •The infant is a product of normal pregnancy and delivery, including C-section.
- •Parental ability to attend visits and interviews and willing to fill questionnaires.
排除标准
- •Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
- •The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
- •The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
- •The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
- •The infant or mother was treated with antibiotics around birth.
结局指标
主要结局
Intestinal flora composition
时间窗: Baseline, 5 weeks
infant feces microbial analysis
次要结局
- Anthropometric measurements(Baseline, 5 weeks)
- General Health and Well being(Baseline, 5 weeks)