GRANDIOSA - Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 4
- 主要终点
- Weight
研究概览
简要总结
Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants.
Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants.
New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk.
The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each formula in the study will have the same packaging besides from colour coding (green, blue, yellow). None of the study personnel are aware of which colour represents which formulae during the course of the intervention.
入排标准
- 年龄范围
- 4 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants born at term
- •Birth weight 2500 to 4500 gram
- •Either exclusive breast-feeding (reference group) or exclusive formula-feeding (intervention and control group)
排除标准
- •Suspected or verified food allergy
- •Suspected or verified infant colic
结局指标
主要结局
Weight
时间窗: At 5 months of age
Primary outcome is weight Standard Deviation Score (SDS) at the end of the intervention.
次要结局
- Metabolic biomarkers in blood.(At enrollment at 2 months of age and at the end of the intervention at 5 months of age.)
- Gastrointestinal immunology.(At enrollment at 2 months of age and during the intervention up to 5 months of age.)
- Eczema severity, parent report.(At enrollment at 2 months of age and during the intervention up to 5 months of age.)
- Length.(At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.)
- Head circumference.(At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.)
- Microbiota(At enrollment at 2 months of age and during the intervention up to 5 months of age.)
- Body composition(At 4 months of age)
- Eczema severity, clinical assessment.(At enrollment at 2 months of age and during the intervention up to 5 months of age.)
- Neurodevelopment at 3 years of age.(At 3 years of age)
- Neurodevelopment at 6 months of age.(At 6 months of age.)
- Neurodevelopment at 12 months of age.(At 12 months of age.)
- Gastrointestinal tolerance.(At enrollment at 2 months of age and during the intervention up to 5 months of age.)
- Allergy.(At enrollment at 2 months of age and at the end of the intervention at 5 months of age.)
- Immunologic activity.(At enrollment at 2 months of age and at the end of the intervention at 5 months of age.)
- Markers of protein metabolism.(At enrollment at 2 months of age and at the end of the intervention at 5 months of age.)