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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stunting of Growth; Chronic Malnutrition
• Intervention / Treatment: Dietary supplement: Tenebrio Molitor powder; Dietary supplement: Control Group (Maize-Soy supplement)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nerea Martín Calvo, PhD; Phone Number: +34 629 34 79 56; Email: nmartincalvo@unav.es
• Study Contact Backup: Name: Andrea Aquino Blanco, Nutritionist; Phone Number: +34 692468366; Email: nmartincalvo@unav.es

Study Locations

• Democratic Republic of the Congo
  • Bukavu, Democratic Republic of the Congo
    • Kesho Congo
    • Contact: Adolphe Nyakasane, Pediatritian; Phone Number: +243 820 422 427; Email: adolphe.nyakasane@keshocongo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks.	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.
Active Comparator: Control Group; Participants will receive a daily supplement made from maize and soy flour for 24 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Iron Concentration (µg/dL)	To determine whether Tenebrio molitor flour improves serum iron levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Zinc Concentration (µg/dL)	To determine whether Tenebrio molitor flour improves serum Zinc levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Vitamin B12 Concentration (pg/mL)	To determine whether Tenebrio molitor flour improves serum Vitamin B12 levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Vitamin B9 (Folate) Concentration (µg/dL)	To determine whether Tenebrio molitor flour improves serum Vitamin B9 (Folate) levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Vitamin A Concentration (µg/dL)	To determine whether Tenebrio molitor flour improves serum Vitamin A levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Calcium Concentration (mg/dL)	To determine whether Tenebrio molitor flour improves serum Calcium levels compared to maize-soy flour.	From Baseline to 24 Weeks
Change in Serum Magnesium Concentration (mg/dL)	To determine whether Tenebrio molitor flour improves serum Magnesium levels compared to maize-soy flour.	From Baseline to 24 Weeks

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Fundación Amigos de Monkole
• Investigators: Study Director: Nerea Martín Calvo, University of Navarra

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stunting; Food Security; Chronic Malnutrition; Tenebrio Molitor; Sustainable Foods
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Growth Disorders; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: SANTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No