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| Name | Class |
|---|---|
| Fundación Amigos de Monkole | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks. |
|
| Control Group | Active Comparator | Participants will receive a daily supplement made from maize and soy flour for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Children whose families agree to participate in the intervention and sign the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nerea Martín Calvo, PhD | Contact | +34 629 34 79 56 | nmartincalvo@unav.es | |
| Andrea Aquino Blanco, Nutritionist | Contact | +34 692468366 | nmartincalvo@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Nerea Martín Calvo | University of Navarra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kesho Congo | Bukavu | Democratic Republic of the Congo |
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| 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. |
|
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 |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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