The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Change in IGF-I between study arms
研究概览
简要总结
The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children
详细描述
The main objective is to assess how different protein blends affect growth factors in children. There is evidence to support that milk protein increases growth in children in both high and low-income countries. Therefore milk protein is often used in food aid for undernourished children in low-income countries. The study investigates if plant protein can partially replace milk protein without affecting growth promotion negatively. Plant protein could potentially reduce food aid costs and at the same time be a more sustainable protein source.
The PROGRO study is a 3-arm randomized, controlled trial. The effect of consuming 35 g pure milk protein/day is compared to intake of 35 g milk and rapeseed protein/day (ratio 30:70 and 54:46, respectively) in 7-8 year old healthy Danish children. The intervention period is 4 weeks and measurements and blood sampling are performed at baseline, week 1 and week 4. A 3-day weighed dietary intake is recorded before each visit. The primary outcome is Insulin-like growth factor-1 (IGF-1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 7-8 years
- •Healthy*
- •The child is willing to consume protein powder twice a day for 4 weeks
- •The child is not a picky eater and so does not mind trying new foods and flavours
- •The child speaks Danish in order to understand the study procedures
- •The parents read and speak Danish in order to be properly informed about the study procedures
- •Written informed consent has been obtained
- •The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved
排除标准
- •The child drinks more than 350 ml of milk per day
- •Known or suspected allergy, sensitization or intolerance to milk (protein or lactose), rapeseed or mustard
- •Any acute illness*
- •Chronic illness or disease that may affect protein metabolism or growth*
- •Chronic intake of medicine that may affect protein metabolism or growth*
- •Concomitant participation in other studies involving dietary supplements or blood sampling
- •Living in a household with another participating child
- •The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved
结局指标
主要结局
Change in IGF-I between study arms
时间窗: from baseline to week 4
Blood sample
次要结局
- Change in IGF-1 within study arms(from baseline to week 4)
- Change in insulin between and within study arms(from baseline to week 1 and week 4, respectively)
- Change in the ratio IGF-1/IGFBP-3 between and within study arms(from baseline to week 1 and week 4, respectively)
- Change in relative insulin resistance between and within study arms(from baseline to week 1 and week 4, respectively)
- Change in IGF-1 between and within study arms(from baseline to week 1)
- Change in IGFBP-3 between and within study arms(from baseline to week 1 and week 4, respectively)
- Change in beta cell function between and within study arms(from baseline to week 1 and week 4, respectively)
- Change in beta cell function/insulin resistance between and within study arms(from baseline to week 1 and week 4, respectively)
研究者
Christian Mølgaard
Professor
University of Copenhagen