Clinical trial NCT06739629: Refugee Insect Production for Food and Feed: the School Meal Intervention
Official title: The School Meal Intervention: the Effect of Yellow Mealworm-enriched Maize Porridge on Nutrition and Health Status of 6-9-year-old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Makerere University
name: International Centre of Insect Physiology and Ecology (ICIPE)
name: Mothers Against Malnutrition and Hunger
name: Child and Family Health, Uganda
name: Research and Action for Income Security
First posted: 2024-12-18
Enrollment: 342
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized intervention
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Change in linear growth based on absolute height gain over 3 months intervention period
timeFrame: 3 months
Secondary outcomes:
measure: Change in myeloperoxidase (MPO) over 3 months intervention period
timeFrame: 3 months
measure: Change in alpha-1-anti-trypsin (AAT) over 3 months intervention period
timeFrame: 3 months
measure: Change in in Neopterin (NEO) over the 3 months intervention period
timeFrame: 3 months
measure: Change in weight over the 3 months intervention period
timeFrame: 3 months
measure: Change in BMI- for- age Z-score over 3 months intervention period
timeFrame: 3 months
measure: Change in Height- for-age Z-score over the 3 months intervention period
timeFrame: 3 months
measure: Change in Weight- for-age Z-score over the 3 months intervention period
timeFrame: 3 months
measure: Change in Mid-Upper Arm Circumference (MUAC) over the 3 months intervention period
timeFrame: 3 months
measure: Change in Subscapular and Triceps skinfold thickness over 3 months intervention period
timeFrame: 3 months
measure: Change in waist circumference measurement over 3 months intervention period
timeFrame: 3 months
measure: Change in fat mass over the 3 months intervention period
timeFrame: 3 months
measure: Change in fat free mass over the 3 months intervention period
timeFrame: 3 months
measure: Change in fat mass index over the 3 months intervention period
timeFrame: 3 months
measure: Change in fat free mass index over 3 months intervention period
timeFrame: 3 months
measure: Change in C- reactive protein (CRP) over the 3 months intervention period
timeFrame: 3 months
measure: Change in alpha-1-acid glycoprotein (AGP) over the 3 months intervention period
timeFrame: 3 months
measure: Change in insulin like growth factor (IGF-1) over the 3 months intervention period
timeFrame: 3 months
measure: Change in hemoglobin over the 3 months intervention period
timeFrame: 3 months
measure: Change in ferritin over the 3 months intervention period
timeFrame: 3 months
measure: Change in soluble transferrin receptor (sTfR) over the 3 months intervention period
timeFrame: 3 months
measure: Change in cobalamin over the 3 months intervention period
timeFrame: 3 months
measure: Change in retinol binding protein (RBP) over the 3 months intervention period
timeFrame: 3 months
measure: Change in methyl malonic acid (MMA) over the 3 months intervention period
timeFrame: 3 months
measure: Change in citrulline over the 3 months intervention period
timeFrame: 3 months
Other outcomes:
Locations:
city: Kyegegwa
country: Uganda
facility: Kako and Bukere Primary School
Study officials:
affiliation: Makerere University
name: Ezekiel Mupere, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: