SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
| Registry | NCT07284095, acronym SANTE |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 40 (Estimated) |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra (Other); collaborators: Fundación Amigos de Monkole |
| Conditions | Chronic Malnutrition, Stunting of Growth |
| Interventions | Tenebrio Molitor powder, Control Group (Maize-Soy supplement) (Dietary supplement) |
| Dates | start 2026-02-01 (estimated), primary completion 2026-02-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-12-16, last updated 2025-12-16 |
| Locations | 1 site in Democratic Republic of the Congo |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Tenebrio Molitor powder | Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks. |
| Control Group | Active comparator | Dietary Supplement: Control Group (Maize-Soy supplement) | Participants will receive a daily supplement made from maize and soy flour for 24 weeks. |
Sex: All, ages: 2 Years to 10 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Kesho Congo | Bukavu | Democratic Republic of the Congo |