Comprehensive studies on nutritional characterization of drumstick leaves (Moringa oleifera) and efficacy testing in young children (6-24 months age group) on growth and micronutrient status
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Feasible nutrient dense semi-perishable food formulations with high protein quality, prepared from diverse local foods and drumstick leaves will be developed for complementary feeding, tested for organoleptic properties and acceptability among children, mothers and healthy adult participants and further intervention trial on its impact on growth, anemia and micro nutrient (Vitamin A) status will be tested among young children .
研究概览
简要总结
According to National Family Health Survey-5 the prevalence of underweight, wasting, stunting, and anemia among under 5 years children is reported to be high i.e., 32.1%, 19.3%, 35.5% and 67.1% respectively. Further the Comprehensive National Nutrition Survey CNNS study (2016-2018) also reported considerable prevalence of micronutrient deficiencies among 1-4 young children (32% of Iron deficiency, 19% of zinc deficiency, 18% of Vitamin A deficiency,) which poses a significant risk to undesirable health. There is a need to address these issues by implementing strategies to enhance healthy food and nutrient intakes through dietary interventions that include food to food fortification and supplementation strategies that can be crucial in reducing malnutrition, micronutrient deficiencies and improving overall child health and nutritional status. Incorporating nutrient-dense foods like Moringa oleifera into young child diets can contribute significantly in addressing these issues since it is a good source of calcium (Ca), protein and iron (Fe), and other bioactive compounds. It is worth exploring the potential of drumstick leaves fortified complementary food mix to improve growth and micronutrient status of young children. However, Moringa leaves are not popularly used in regular diets, and there are limited studies reported on the potential use of Moringa leaves in a food-to-food fortification perspective. Therefore, this study intends to optimize blended complementary food mix incorporating moringa leaf powder, test its acceptability and effect on growth, anemia and micronutrient status among 6–24-month-old children. The composition of nutrients and bio-actives present in moringa leaves, the effect of domestic processing on nutrient retention and bio-availability of selected micro nutrients will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Children: All children in the age group of 6 to 24 months identified as beneficiaries of SNP-ICDS and their mothers/caregivers residing in urban slum within Hyderabad.
- •Consuming solid foods / THR for at least the past 30 days.
- •Apparently healthy, not presently suffering from acute illness.
- •(fever, cough, cold, etc..,).
- •No known food allergies.
- •Children with moderate anemia, mild anemia and those with normal haemoglobin (Hb) status Have weight for age, height for age and/or weight for height greater than or equal to -3 z score.
- •Have written informed consent from their parents, and Planning to remain in the trial area and continue for the entire duration of the study For adult sensory panel: The members of the sensory panel who are in the age group of 20-39 years, having no current illness such as fever, gastrointestinal disturbances, food intolerance/allergies, no taste/odour perception disorders, no color blindness, no denture defects, no minor infections of nose and throat, and willing to participate during all the time points will be selected and included in the study.
排除标准
- •Children who : have haemoglobin (lesser than 8 g per dL) are severely undernourished (WAZ, HAZ and WHZ lesser than -3 z scores).
- •are not the beneficiaries of ICDS are excluded.
- •do not consume the existing THR the past 30 days.
- •are suffering from acute/chronic illness have known allergy to milk products, wheat products, nuts etc.
- •refuse to participate in the trial are participating in any other research trial For adults, all who do not satisfy the inclusion criteria.
结局指标
主要结局
Feasible nutrient dense semi-perishable food formulations with high protein quality, prepared from diverse local foods and drumstick leaves will be developed for complementary feeding, tested for organoleptic properties and acceptability among children, mothers and healthy adult participants and further intervention trial on its impact on growth, anemia and micro nutrient (Vitamin A) status will be tested among young children .
时间窗: 18 months
次要结局
- To develop and standardize Moringa based recipes(incorporating moringa leaves in commonly consumed recipes) and estimating the contribution of the moringa based food mixes and the standardized recipes to the Estimated Average Requirements of macronutrients and micronutrients such as vitamin A, calcium and iron in different vulnerable age, gender and physiological groups.(5 months)
- To assess the effect of food processing including different drying and cooking methods on retention and bioavailability of beta-carotene, calcium, iron and content of selected bio-active components in the optimized food mixes and standardized recipes.(10 months)
- Final data management and reporting(3 months)
研究者
Dr Madhari Srisailam Radhika
ICMR- National Institute of Nutrition