Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenebrio Molitor powder, Control Group (Maize-Soy supplement).
- Who it may be relevant to
- Registry conditions: Chronic Malnutrition, Stunting of Growth. Basic parameters: 2 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
Overview
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.
Interventions
- 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 ani - 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.
Primary outcome measures
- Prealbumin [Time frame: Baseline (Week 0) and 24 weeks of supplementation.]
- Height-for-Age z-scores (WHO Child Growth Standards) [Time frame: Baseline, 12 weeks and 24 weeks]
Secondary outcome measures (7)
- Change in Serum Iron Concentration (µg/dL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Zinc Concentration (µg/dL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Vitamin B12 Concentration (pg/mL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Vitamin B9 (Folate) Concentration (µg/dL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Vitamin A Concentration (µg/dL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Calcium Concentration (mg/dL) [Time frame: From Baseline to 24 Weeks]
- Change in Serum Magnesium Concentration (mg/dL) [Time frame: From Baseline to 24 Weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Democratic Republic of the Congo · 1 center
- Kesho Congo — Bukavu
Identifiers
NCT: NCT07284095 · SANTE