Pilot study to optimize the level of protein in products for Indian primary school children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference
研究概览
简要总结
Undernutrition is responsible for ~35% of deaths in children under 5 years of age1. Long termchildhood malnutrition is associated with reduced height achieved in adulthoodas well as increased risk of chronic disease2. This studyaims to develop affordable and sustainable sources of food products andsupplements that will improve growth parameters of children from diversesocioeconomic backgrounds.
Thoughintense efforts are going on to develop affordable healthy foods to improvenutritional status of growing children, high inter-individual variations ingenetic background, access to health care, living conditions, amongst otherscan make the use of longer-term outcomes such as growth parameters challenging3,4. Changes in theprofile of metabolic intermediates and other signaling molecules can provide anearlier read-out of the effects of nutritional interventions in such a setting.Though a few previous studies have examined protein and lipid kinetics inmalnourished children, till date only Bartz et al have systematically analyzedthis through the effect of in-patient milk-based formulations and out-patientsupplementation with ready-to-use therapeutic food (RUTF) on children withsevere acute malnutrition (SAM) by targeted and non-targeted metabolomicanalysis.
Asthere is a dearth of studies assessing early and accurate markers of the effectof nutritional formulations on growing children, we propose to rapidly assessthe systemic effects of novel food products on the growth of stunted butotherwise healthy primary school children through changes in the metabolome andthe microbiome. Such markers can then be utilized in the future for testingefficacy of a variety of nutritional formulations for selecting the mosteffective, affordable and sustainable ones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Parents willing to give an informed consent and subjects willing to give assent.
- •2.Boys and girls aged between 6-10 years.
- •3.Children with Z-scores of less than -2.
- •4.Mildly anemic (Hb<12 g/dL).
排除标准
- •1.Recent history (3 months) of serious infections, injuries and/ or surgeries.
- •2.Use of any prescription medications.
- •3.Children consuming nutritional supplements and/ or health food drinks on a regular basis.
- •4.Food allergies.
结局指标
主要结局
1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference
时间窗: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.
2.Intestinal microbiota stool sample
时间窗: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.
3.Serum, urine metabolomics
时间窗: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.
次要结局
- Micronutrient status: Hb, Serum folate, B12, ferritin, plasma iron, plasma zinc, renal and liver function test(Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.)