NCT06739629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

November 22, 2024

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (24)

  • 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

  • +19 more secondary outcomes

Study Arms (2)

Yellow mealworm-enriched porridge

EXPERIMENTAL

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

Other: Insect porridge

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.

Other: Maize Porridge

Interventions

Yellow mealworm porridge

Also known as: Yellow mealworm porridge, Edible insect porridge
Yellow mealworm-enriched porridge

Maize porridge

Also known as: porridge
Maize porridge

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kako and Bukere Primary School

Kyegegwa, Uganda

Location

Study Officials

  • Ezekiel Mupere, PhD, MD

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data collectors assessing anthropometric measures, dietary records and questionnaires were masked
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm randomized intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 18, 2024

Study Start

June 17, 2024

Primary Completion

October 25, 2024

Study Completion

October 25, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations