Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stool biochemistry - soaped fatty acids
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
详细描述
In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption.
Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions.
Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula.
InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position.
The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.
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
- 1 Day 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants: gestation 37-40 weeks
- •Birth weight 2500-4000 g
- •Apparent good health
- •The infant is a product of normal pregnancy and delivery.
排除标准
- •Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- •Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
- •Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
- •Born with a 5- or 10-minute Apgar score <7
- •Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- •Breast-feeding for a week or over.
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.
结局指标
主要结局
Stool biochemistry - soaped fatty acids
时间窗: 6 weeks
次要结局
- Stool biochemistry - total fatty acids and calcium content(6 weeks)
- Stool characteristics - 7days diaries(3 months)
- General health(3 months)
- Anthropometric parameters(3-6 months)