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

University of Navarra

Status: Not yet enrolling

Conditions: Stunting of Growth; Chronic Malnutrition

Treatments: Dietary Supplement: Control Group (Maize-Soy supplement); Dietary Supplement: Tenebrio Molitor powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07284095

SANTE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants will receive a daily supplement made from Tenebrio molitor (mealworm) flour for 24 weeks.

Treatment:

Dietary Supplement: Tenebrio Molitor powder

Control Group

Active Comparator group

Description:

Participants will receive a daily supplement made from maize and soy flour for 24 weeks.

Treatment:

Dietary Supplement: Control Group (Maize-Soy supplement)