Refugee Insect Production for Food and Feed: the School Meal Intervention (REFIPRO)

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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Other: Insect porridge; Other: Maize Porridge

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kyegegwa, Uganda
    • Kako and Bukere Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yellow mealworm-enriched porridge; Participants receive a daily meal of yellow mealworm-enriched porridge, served in schools. The porridge provides 420 Kcal/serving	Other: Insect porridge; Yellow mealworm porridge; Other Names: Yellow mealworm porridge; Edible insect porridge
Other: Maize porridge; Participants receive a standard maize porridge served in schools. This porridge is comparable to the porridge served in the parent-led school feeding program.	Other: Maize Porridge; Maize porridge; Other Names: porridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in linear growth based on absolute height gain over 3 months intervention period	Assessing the effect of the intervention on height gain measured in cm	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in myeloperoxidase (MPO) over 3 months intervention period	Assessing the effect of the intervention on myeloperoxidase (ng/mL), which is a stool marker for Environmental Enteric Dysfunction (EED). A high value indicates high intestinal inflammation.	3 months
Change in alpha-1-anti-trypsin (AAT) over 3 months intervention period	Assessing the effect of the intervention on alpha-1-anti-trypsin (mg/g) which is a stool marker for Enteric Environemtal Dysfunction ( EED). A high value indicates high intestinal protein loss.	3 months
Change in in Neopterin (NEO) over the 3 months intervention period	Assessing the effect of the intervention on Neopterin ( nmol/L) which is a stool marker for Enteric Environemtal Dysfunction (EED). A high value indicates intestinal inflammation.	3 months
Change in weight over the 3 months intervention period	Assessing the effect of the intervention on weight gain (kg)	3 months
Change in Height- for-age Z-score over the 3 months intervention period	Assessing the effect of the intervention on height-for-age Z-score values using the cut offs: < -2 to -3 HAZ moderately stunted, HAZ < -3 severely stunted	3 months
Change in Weight- for-age Z-score over the 3 months intervention period	Assessing the effect of the intervention on weight-for-age Z-score using the cut offs: -2 to-3 WAZ moderately underweight, WAZ < -3 severely underweight	3 months
Change in Mid-Upper Arm Circumference (MUAC) over the 3 months intervention period	Assessing the effect of the intervention on the Mid-Upper Arm Circumference in cm using the cut-offs: <13.5cm severe acute malnutrition, 13.5cm -14.5cm moderate acute malnutrition.	3 months
Change in fat mass over the 3 months intervention period	Assessing the effect of the intervention on fat mass measured in kgs using deuterium dilution method and bioimpedance analyzer. Low fat mass indicates healthier body composition.	3 months
Change in fat free mass over the 3 months intervention period	Assessing the effect of the intervention on fat free mass measured in kg using deuterium dilution method and bioimpedance analyzer. A high fat free mass indicates high muscle mass and healthier body composition.	3 months
Change in fat free mass index over 3 months intervention period	Assessing the effect of the intervention on fat free mass index ( FFMI) measured in kg/m2 using deuterium dilution method and bioimpedance analyzer. A high fat free mass index indicates high muscle mass and healthier body composition	3 months
Change in C- reactive protein (CRP) over the 3 months intervention period	Assessing the effect of the intervention on C-reactive Protein(mg/L) which is a blood marker for systemic inflammation. High CRP values indicate systemic inflammation.	3 months
Change in alpha-1-acid glycoprotein (AGP) over the 3 months intervention period	Assessing the effect of the intervention on alpha-1-acid glycoprotein (g/L) which is a blood marker for systemic inflammation. High AGP values indicate systemic inflammation.	3 months
Change in hemoglobin over the 3 months intervention period	Assessing the effect of the intervention on hemoglobin measured in g/dL. Low hemoglobin levels indicate Anemia.	3 months
Change in ferritin over the 3 months intervention period	Assessing the effect of the intervention on serum ferritin measured in μg/L. A low level of serum ferritin indicates Anemia.	3 months
Change in cobalamin over the 3 months intervention period	Assessing the effect of the intervention on cobalamin measured in pmol/L. A low level of cobalamin is associated with Vitamin B12 deficiency.	3 months
Change in retinol binding protein (RBP) over the 3 months intervention period	Assessing the effect of the intervention on serum retinol binding protein (RBP) measured in µmol/l. A low level of RBP is associated with Vitamin A deficiency.	3 months
Change in BMI- for- age Z-score over 3 months intervention period	Assessing the effect of the intervention on BMI-for-age Z-score, by combining weight (Kg) and Height (m2) to report BMI (kg/m2) using the cut offs: Overweight: >+1SD, Obesity: >+2SD, Thinness: <-2SD, Severe thinness: <-3SD	3 months
Change in Subscapular and Triceps skinfold thickness over 3 months intervention period	Assessing the effect of the intervention on subscapular and triceps skinfold thickness measured in mm.	3 months
Change in waist circumference measurement over 3 months intervention period	Assessing the effect of the intervention on waist circumference measured in cm.	3 months
Change in fat mass index over the 3 months intervention period	Assessing the effect of the intervention on fat mass index measured in kg/m2, using deuterium dilution method and bioimpedance analyzer. Low fat mass index indicates a healthier body composition.	3 months
Change in insulin like growth factor (IGF-1) over the 3 months intervention period	Assessing the effect of the intervention on insulin like growth factor (ng/mL) which is a blood markers for growth. High IGF-1 values support growth.	3 months
Change in soluble transferrin receptor (sTfR) over the 3 months intervention period	Assessing the effect of the intervention on soluble transferrin receptor measured in mg/L. A high level of sTfR is associated with Anemia.	3 months
Change in methyl malonic acid (MMA) over the 3 months intervention period	Assessing the effect of the intervention on methyl malonic acid (MMA) measured in nmol/L. A high level of MMA indicates Vitamin B12 deficiency.	3 months
Change in citrulline over the 3 months intervention period	Assessing the effect of the intervention on plasma citrulline measured in μmol/L. A low level of citrulline indicates impaired intestinal function.	3 months

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Makerere University; International Centre of Insect Physiology and Ecology (ICIPE); Mothers Against Malnutrition and Hunger; Child and Family Health, Uganda; Research and Action for Income Security
• Investigators: Principal Investigator: Ezekiel Mupere, PhD, MD, Makerere University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: S400- REFIPRO STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No