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临床试验/NCT06739629
NCT06739629已完成不适用

The School Meal Intervention: the Effect of Yellow Mealworm-enriched Maize Porridge on Nutrition and Health Status of 6-9-year-old Children

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2024年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
342
试验地点
1
主要终点
Change in linear growth based on absolute height gain over 3 months intervention period

研究概览

简要总结

The goal of this randomized controlled trial is to assess whether edible insect-enriched school porridge has nutrition and health benefits for children aged 6-9 years in refugee communities in Uganda.

The main question the research aims to answer is: Does a daily serving of maize porridge enriched with yellow mealworm flour improve the gut health, growth, and micronutrient status of children in comparison to a standard maize porridge?

Participants will:

Consume a daily serving of yellow mealworm porridge or a maize porridge for one school term (3 months). Data is collected before, during and after the intervention period.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Data collectors assessing anthropometric measures, dietary records and questionnaires were masked

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children in Primary 1 in Bukere and Kako primary school
  • •Age: 6-9 years
  • •Child can eat insects
  • •Written informed consent given by parent/caregiver

排除标准

  • •Severe acute malnutrition measured as MUAC < 13.5 cm
  • •Known allergies related to consuming insects
  • •Disability that impedes eating capacity
  • •Disability that makes height assessment problematic
  • •Family plans to move away or deregister child from Kako and Bukere primary schools within the school term.

研究组 & 干预措施

Yellow mealworm-enriched porridge

Experimental

Participants receive a daily meal of yellow mealworm-enriched porridge, served in schools. The porridge provides 420 Kcal/serving

干预措施: Insect porridge (Other)

Maize porridge

Other

Participants receive a standard maize porridge served in schools. This porridge is comparable to the porridge served in the parent-led school feeding program.

干预措施: Maize Porridge (Other)

结局指标

主要结局

Change in linear growth based on absolute height gain over 3 months intervention period

时间窗: 3 months

Assessing the effect of the intervention on height gain measured in cm

次要结局

  • Change in in Neopterin (NEO) over the 3 months intervention period(3 months)
  • Change in weight over the 3 months intervention period(3 months)
  • Change in myeloperoxidase (MPO) over 3 months intervention period(3 months)
  • Change in alpha-1-anti-trypsin (AAT) over 3 months intervention period(3 months)
  • Change in BMI- for- age Z-score over 3 months intervention period(3 months)
  • Change in Height- for-age Z-score over the 3 months intervention period(3 months)
  • Change in Weight- for-age Z-score over the 3 months intervention period(3 months)
  • Change in Mid-Upper Arm Circumference (MUAC) over the 3 months intervention period(3 months)
  • Change in Subscapular and Triceps skinfold thickness over 3 months intervention period(3 months)
  • Change in waist circumference measurement over 3 months intervention period(3 months)
  • Change in fat mass over the 3 months intervention period(3 months)
  • Change in fat free mass over the 3 months intervention period(3 months)
  • Change in fat mass index over the 3 months intervention period(3 months)
  • Change in fat free mass index over 3 months intervention period(3 months)
  • Change in C- reactive protein (CRP) over the 3 months intervention period(3 months)
  • Change in alpha-1-acid glycoprotein (AGP) over the 3 months intervention period(3 months)
  • Change in insulin like growth factor (IGF-1) over the 3 months intervention period(3 months)
  • Change in hemoglobin over the 3 months intervention period(3 months)
  • Change in ferritin over the 3 months intervention period(3 months)
  • Change in soluble transferrin receptor (sTfR) over the 3 months intervention period(3 months)
  • Change in cobalamin over the 3 months intervention period(3 months)
  • Change in retinol binding protein (RBP) over the 3 months intervention period(3 months)
  • Change in methyl malonic acid (MMA) over the 3 months intervention period(3 months)
  • Change in citrulline over the 3 months intervention period(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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