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Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo

NCT07284095 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-16

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a dietary supplement based on Tenebrio molitor (mealworm flour) can improve nutritional status and biomarkers of micronutrient deficiency in children aged 2-10 years.

The main questions it aims to answer are:

• Does regular supplementation with Tenebrio molitor flour improve chronic malnutrition status

Researchers will compare the intervention group (children receiving Tenebrio molitor flour supplement) with the control group (children receiving a traditional maize-soy flour supplement) to assess differences in biochemical and anthropometric outcomes after the intervention period.

Participants will:

* Participate in baseline and follow-up anthropometric and blood sample assessments (hemoglobin, albumin, zinc, iron, calcium, magnesium, vitamin A, folic acid, vitamin B12, prealbumin).
* Consume a daily dietary supplement (either Tenebrio molitor flour or maize-soy flour) for the duration of the intervention.
* Provide information on dietary intake and general health status through structured questionnaires administered by the research team.

Conditions

  • Chronic Malnutrition
  • Stunting of Growth

Interventions

DIETARY_SUPPLEMENT

Tenebrio Molitor powder

The intervention consists of a daily dietary supplement made from Tenebrio molito powder, a sustainable and high-protein insect. Each participant in the intervention group will receive a pre-measured daily dose of Tenebrio molitor The supplement is designed to improve protein quality and micronutrient intake, particularly iron, zinc, and vitamin B12, in children aged 2-10 years. This intervention differs from traditional nutritional supplements by using Tenebrio molitor as a novel source of animal protein and micronutrients, contributing to sustainable food systems and child nutrition in low-resource settings.

DIETARY_SUPPLEMENT

Control Group (Maize-Soy supplement)

The control supplement is a daily dietary mixture made from maize and soy flour, formulated to match the dose of the intervention supplement but without Tenebrio molitor protein. This preparation represents a conventional plant-based dietary supplement commonly used in nutritional support programs. It serves as an active comparator to assess the added nutritional and functional benefits of Tenebrio molitor flour in improving biochemical and anthropometric indicators of child nutrition.

Sponsors & Collaborators

  • Fundación Amigos de Monkole

    collaborator UNKNOWN

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Nerea Martín Calvo · University of Navarra

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-02-28
Completion
2026-08-31

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284095 on ClinicalTrials.gov