Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evolution of growth of infants
研究概览
简要总结
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.
The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.
This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0 to 3 weeks
- •Child followed by a general practitioner or pediatrician
- •Informed consent form signed by the legal representatives of the subject
- •Commitment of legal representatives to follow the constraints generated by the study
排除标准
- •Infant born prematurely before 37 weeks of amenorrhea
- •Child allergic to cow's milk proteins
- •Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
- •Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
- •Incapacity for the legal representative(s) to understand or adhere to the protocol
- •Subject involved in another clinical study or in an exclusion period from another study
- •Legal representatives deprived of liberty
- •Legal representatives in a position to judicial protection
- •Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- •Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards
- •The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.
研究组 & 干预措施
Breast milk
group receiving breastfeeding
干预措施: Breastfeeding (Other)
infant formula conventional BIO
infant formula with conventional whey BIO
干预措施: Conventional BIO Infant formula (Other)
infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
干预措施: TrueGreen BIO infant formula (Other)
结局指标
主要结局
Evolution of growth of infants
时间窗: from 0 to 6 months
Weight in kilograms
次要结局
- Number of wake up per night(from 0 to 6 months)
- Height evolution of infants(from 0 to 6 months)
- BMI evolution of infants(from 0 to 6 months)
- Head circumference evolution of infants(from 0 to 6 months)
- Number of colic per day(from 0 to 6 months)
- Consistency of stool(from 0 to 6 months)
- Number of regurgitation(from 0 to 6 months)
- Total sleep time per day(from 0 to 6 months)
- Plasma amino acid profile(between 3rd and 4th month)
- Metabolomic analysis from plasma and urine samples(between 3rd and 4th month)
研究者
Jean-Michel Lecerf
Professor
Institut Pasteur de Lille