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临床试验/CTRI/2023/03/050244
CTRI/2023/03/050244尚未招募2 期

Nutrient dense (No sugar and Low sugar) take home ration food mixes for complementary feeding using locally available diverse foods - A comprehensive study on product optimization and effect of food processing on sensorial properties, product acceptability, nutrient retention, bioavailability and shelf-life.

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月13日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Feasible nutrient dense semi-perishable food formulations with a higher protein quality,

研究概览

简要总结

Complementary feeding for infants refers to the timely introduction of nutrient-rich foods in addition to breastfeeding and are needed to fill the gap between the total requirements of the child and the amount provided by breast milk. Inadequate intake in this period and beyond can affect growth, development and metabolism, having longâ€term health effects . Habitual diets of under 2y old children in India are suboptimal, are of low protein quality, as well as low in healthy fats and micronutrient density, which may have undesirable health impacts. Nutrition specific and nutrition-sensitive interventions during this vulnerable period are required to maximize health benefits, as interventions after this period may have little impact. The Government of India has launched a program called the Integrated Child Development Services (ICDS) under the aegis of Ministry of Women and Child Development (MoWCD), which offers a variety of nutrition and health services to impact the first 1,000 days of life and beyond and is implemented by all the state governments. In the states of Telangana and Andhra Pradesh, a predominantly cereal-based blended flour with little amounts of pulses milk powder and plant-based oil and a very high amount of added free sugars (>20%), is provided to 06-35-month-old children which is supplied as a Take-Home Ration (THR).WHO suggests adults and children to lower their daily consumption of free sugars to less than 10% of their total energy intake for good health and recommends further reduction to less than 10% of total energy, as this would provide improved health benefits. Further, ICMR-NIN updated the Indian food composition tables in 2017 and has more recently published the “Nutrient Requirements for Indians†and also created the “My plate for the Day†in 2020, indicating food-based recommendations in terms of the proportion of foods to be sourced from eight diverse essential food groups to meet the nutrient requirements. In line with these recent developments, we wish to develop nutrient-dense food mixes for complementary feeding, one with no added refined sugar and another with low sugar (5-10% by weight), using locally available foods sourced from diverse food groups and test the effects of food processing on their nutrient content, bio-availability, sensory properties and shelf-life. Further, the acceptability of these formulations will be tested in the target group of 12–24-month-old ICDS children. The active control formulation in this study would be the existing THR .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
12.00 Month(s) 至 30.00 Month(s)(—)
性别
All

入选标准

  • All children in the age group of 12-30 months identified as beneficiaries of SNP-ICDS and their mothers/caregivers.
  • ï‚· Consuming solid foods for at-least the past 30 days.
  • Consuming the existing THR products for at least the past 30 days.
  • Apparently healthy, not presently suffering from acute illness.
  • (fever, ARI etc..,).
  • No known allergy to milk products, wheat products, nuts etc.
  • Moderate underweight, stunting and wasting to normal grade children.

排除标准

  • Children who are not the beneficiaries of ICDS are excluded.
  • Children who do not consume the existing THR the past 30 days.
  • Who are suffering from acute/chronic illness Who have known allergy to milk products, wheat products, nuts etc.
  • The members of sensory panel should not be below 20 years and more than 39 years 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 a higher protein quality,

时间窗: 0-7 months

prepared from diverse local foods that are well accepted will be developed for complementary

时间窗: 0-7 months

feeding.

时间窗: 0-7 months

次要结局

  • Effects of selected food processing treatments on retention & bioavailability of selected nutrients(from 6 month-14 month)
  • To test the sensory properties of the child friendly traditional recipes prepared from the food mixes, in an untrained mothers’ panel compared to Balamrutham(from 13th month to 18th month)
  • To assess the acceptability of the recipes prepared using the optimized formulations in 12–30-month-old ICDS child beneficiaries compared to Balamrutham(from 13th month - 19th month)
  • To estimate the shelf life of the formulated food mixes compared to the existing Balamrutham(from 14th month to 19th month)
  • Final Data Management and reporting(from 19th month to 24th month)

研究者

申办方类型
Government funding agency

研究点 (1)

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