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

NCT07284095 | Not Yet Recruiting

• 1 other identifier: SANTE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Malnutrition; Stunting; Tenebrio Molitor; Food Security; Sustainable Foods

Outcome Measures

Primary Outcomes (2)

• Prealbumin

  Prealbumin levels will be measured to assess improvement in protein nutritional status among participants receiving Tenebrio molitor flour supplement compared with those receiving maize-soy flour supplement.

  Baseline (Week 0) and 24 weeks of supplementation.

• Height-for-Age z-scores (WHO Child Growth Standards)

  To evaluate the effect of Tenebrio molitor supplementation on growth parameters in children. Scale range: z-scores less than or equal to -2 indicate stunting; less than or equal to -3 indicate severe stunting. Values close to 0 reflect adequate growth. High positive values (\>+2 or \>+3) indicate heights that are significantly above the average

  Baseline, 12 weeks and 24 weeks

Secondary Outcomes (7)

• Change in Serum Iron Concentration (µg/dL)

  From Baseline to 24 Weeks

• Change in Serum Zinc Concentration (µg/dL)

  From Baseline to 24 Weeks

• Change in Serum Vitamin B12 Concentration (pg/mL)

  From Baseline to 24 Weeks

• Change in Serum Vitamin B9 (Folate) Concentration (µg/dL)

  From Baseline to 24 Weeks

• Change in Serum Vitamin A Concentration (µg/dL)

  From Baseline to 24 Weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks.

Dietary Supplement: Tenebrio Molitor powder

Control Group

ACTIVE COMPARATOR

Participants will receive a daily supplement made from maize and soy flour for 24 weeks.

Dietary Supplement: Control Group (Maize-Soy supplement)

Interventions

Tenebrio Molitor powder DIETARY_SUPPLEMENT

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.

Intervention Group

Control Group (Maize-Soy supplement) DIETARY_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.

Control Group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with chronic malnutrition (weight-for-height or BMI below -2 SD according to WHO standards).
• Children whose families agree to participate in the intervention and sign the informed consent form.

You may not qualify if:

• Children with severe acute illnesses that may interfere with the intervention.
• Children with known allergies to the ingredients of the nutritional products provided.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Fundación Amigos de Monkole: collaborator

Study Sites (1)

Kesho Congo

Bukavu, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Growth Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nerea Martín Calvo

  University of Navarra

  STUDY DIRECTOR

Central Study Contacts

Nerea Martín Calvo, PhD

CONTACT

+34 629 34 79 56; nmartincalvo@unav.es

Andrea Aquino Blanco, Nutritionist

CONTACT

+34 692468366; nmartincalvo@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 16, 2025
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

DE (1)