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Clinical Trials/NCT06739629
NCT06739629
Completed
N/A

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 site in 1 country342 target enrollmentJune 17, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nutrition, Healthy
Sponsor
University of Copenhagen
Enrollment
342
Locations
1
Primary Endpoint
Change in linear growth based on absolute height gain over 3 months intervention period
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2024
End Date
October 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 3 months

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

Secondary Outcomes

  • 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 in Neopterin (NEO) over the 3 months intervention period(3 months)
  • Change in weight over the 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)

Study Sites (1)

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