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.
Children diagnosed with chronic malnutrition (weight-for-height or BMI below -2 SD according to WHO standards).
Children with severe acute illnesses that may interfere with the intervention.
Children with known allergies to the ingredients of the nutritional products provided.
Parallel
Tenebrio Molitor powder
Dietary supplementThe 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 supplementThe 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.
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.
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
Change in Serum Iron Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum iron levels compared to maize-soy flour.
Change in Serum Zinc Concentration (µg/dL)
To determine whether Tenebrio molitor flour improves serum Zinc levels compared to maize-soy flour.
Change in Serum Vitamin B12 Concentration (pg/mL)
To determine whether Tenebrio molitor flour improves serum Vitamin B12 levels compared to maize-soy flour.
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.
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Clinica Universidad de Navarra, Universidad de Navarra
Lead sponsor
Fundación Amigos de Monkole
Collaborator
This trial is not recruiting at the moment. You can still explore other options: