Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.
The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.
详细描述
Developing an IF with A2 β-casein, high proportion of alpha-lactoalbumin and less protein that commercial IF, similar to breast milk (1g/100 mL), could be and important strategy to decrease the risk of diseases. This infant formula was compared with breast milk and two other IF with different protein composition. The three formulas were packed in the same presentation and identified by a number. Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn. the present study
Infants' mothers were recruited from six health centers from the Health Ministry in Querétaro, México. Directors of each health center authorized the protocol study. The field workers were read and explained the informed consent letter, the objectives, procedures, risks and benefits of the study in detail.
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
- Single (Participant)
盲法说明
The participant did not know which formula was assigned. Infant formulas were packed in the same presentation and identified by a number.
入排标准
- 年龄范围
- 1 Day 至 40 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-term newborn (≥37 weeks of gestation)
- •Birth weight ≥2500 g and ≤4000 g
- •Apgar score > 8
- •Infants from birth to 40 days of age at the time of enrollment
- •Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn.
排除标准
- •Infants with congenital heart defect, congenital illness or malformations, severe gastrointestinal disease, kidney, liver, central nervous system, or metabolic disease, or born from mothers with gestational diabetes.
研究组 & 干预措施
IF-VLP (very low protein)
Participants were exclusively fed with an infant formula containing 1g of protein/dL, 26% alpha lactoalbumin, and 100% A2 casein for 4 months.
干预措施: Infant formula (Other)
IF-LP (low protein)
Participants were exclusively fed with an infant formula containing 1.3 g of protein/dL, 26% alpha lactoalbumin, 100% A2 casein for 4 months.
干预措施: Infant formula (Other)
IF-CSP (control standard protein)
Participants were exclusively fed with an infant formula containing 1.5 g of protein/dL, 50% A1 casein and 50% A2 casein for 4 months.
干预措施: Infant formula (Other)
HM (human milk)
Participants were exclusively breastfed
结局指标
主要结局
Change in weight
时间窗: Baseline to 4 months of age
Weight
次要结局
- Beta-casomorphin 7 concentration(Baseline and at 4 months of age)
- Number of gastrointestinal events(Baseline, 1, 2, 3, and 4 months)
- Anthropometry measurements(Baseline, 1, 2 ,3 and 4 months of age)
研究者
Olga Patricia García Obregon
Principal Investigator
Universidad Autonoma de Queretaro