NCT02907502已完成不适用
Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial
Société des Produits Nestlé (SPN)3 个研究点 分布在 2 个国家目标入组 1,618 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,618
- 试验地点
- 3
- 主要终点
- BMI-for-age z-score
研究概览
简要总结
To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life
详细描述
This study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained his/her parents' (or his/her legally accepted representative [LAR's] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
- •Child was born full term (≥ 37 weeks of gestation)
- •Age at enrollment: between 11.5 months and 13.5 months of age
- •2.5 kg ≤ birth weight ≤ 4.5 kg
- •Born from a singleton pregnancy
- •Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.
排除标准
- •Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
- •Cows' milk allergy
- •Lactose intolerance
- •Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
- •Infant who is being breastfed at the time of enrollment
- •Infant who does not usually drink 300ml of cow's and/or formula milk per day
- •Institutionalized children
- •Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
结局指标
主要结局
BMI-for-age z-score
时间窗: Age 24 months
WHO-growth standard
次要结局
- BMI-for-age z-score(Age 72 months)
- The percentage of overweight and obese children(Age 72 months)
- Growth parameters: Anthropometry: Weight, Length, Heel knee length, Mid-arm circumference, Waist circumference, Hip circumference (only 48 months and 72 months), Head circumference, Triceps skinfold, Subscapular skinfold(Age 12, 18, 24, 48 and 72 months)
- Child's development: Parental rating of child development with Ages & Stages Questionnaires®(Age 24 and 48 months)
- Body composition: air displacement plethysmography(at 24, 48 and 72 months of age)
- Metabolomic profile: Plasma and urine metabolic indicators of energy and protein metabolism (metabolomics with a focus on carnitines, amino acid catabolism, ketone bodies, Krebs cycle, and bacterial utilization of protein and carbohydrates)(Age 12, 18, 24, 48 and 72 months)
- DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites)(Age 12, 24 and 72 months)
- Blood pressure(Age 48 and 72 months)
- Dietary intake: 24-hour recall(Age 12, 18, 24, 48 and 72 months)
- Metabolic and endocrine markers: Blood and Urine markers(Age 12, 24 and 72 months)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Effect of the Level of Dietary Protein on Body CompositionGrowth AccelerationNCT01489098Société des Produits Nestlé (SPN)178
已完成
不适用
Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of AgeBottle FeedingNCT02010749Société des Produits Nestlé (SPN)267
进行中（未招募）
不适用
Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid FormulaCow Milk AllergyNCT01637688Mahidol University81
已完成
不适用
The Effect of Milk and Meat on IGFs in Prepubertal BoysGrowth DisordersMetabolic SyndromeNCT00378859University of Copenhagen24
终止
不适用
Observational Study of Infants Fed With Dairy and Plant Based Infant FormulaInfant GrowthParent and Infant User ExperienceNCT05804214Nutricia Research2