Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07284095

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Malnutrition Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stunting of Growth

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Prealbumin

    Time frame: Baseline (Week 0) and 24 weeks of supplementation.

    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.

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

    Time frame: Baseline, 12 weeks and 24 weeks

    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

Secondary outcomes

  1. Change in Serum Iron Concentration (µg/dL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum iron levels compared to maize-soy flour.

  2. Change in Serum Zinc Concentration (µg/dL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Zinc levels compared to maize-soy flour.

  3. Change in Serum Vitamin B12 Concentration (pg/mL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Vitamin B12 levels compared to maize-soy flour.

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

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Vitamin B9 (Folate) levels compared to maize-soy flour.

  5. Change in Serum Vitamin A Concentration (µg/dL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Vitamin A levels compared to maize-soy flour.

  6. Change in Serum Calcium Concentration (mg/dL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Calcium levels compared to maize-soy flour.

  7. Change in Serum Magnesium Concentration (mg/dL)

    Time frame: From Baseline to 24 Weeks

    To determine whether Tenebrio molitor flour improves serum Magnesium levels compared to maize-soy flour.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Aquino Blanco, Nutritionist

CONTACT

[email protected]

+34 692468366

Nerea Martín Calvo, PhD

CONTACT

[email protected]

+34 629 34 79 56

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Fundación Amigos de Monkole

Registry information

Official study title

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

Acronym: SANTE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.