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Набор скоро начнётся NCT07284095

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

Без фазы С лечением Chronic Malnutrition Stunting of Growth

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tenebrio Molitor powder, Control Group (Maize-Soy supplement).
Кому может быть актуально
Состояния в реестре: Chronic Malnutrition, Stunting of Growth. Базовые параметры: 2 лет — 10 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Democratic Republic of the Congo
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Пищевая добавка 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
  • Пищевая добавка 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.

Первичные конечные точки

  • Prealbumin [Срок оценки: Baseline (Week 0) and 24 weeks of supplementation.]
  • Height-for-Age z-scores (WHO Child Growth Standards) [Срок оценки: Baseline, 12 weeks and 24 weeks]
Вторичные конечные точки (7)
  • Change in Serum Iron Concentration (µg/dL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Zinc Concentration (µg/dL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Vitamin B12 Concentration (pg/mL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Vitamin B9 (Folate) Concentration (µg/dL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Vitamin A Concentration (µg/dL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Calcium Concentration (mg/dL) [Срок оценки: From Baseline to 24 Weeks]
  • Change in Serum Magnesium Concentration (mg/dL) [Срок оценки: From Baseline to 24 Weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Children with severe acute illnesses that may interfere with the intervention.
  • Children with known allergies to the ingredients of the nutritional products provided.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Democratic Republic of the Congo · 1 центр
  • Kesho Congo — Bukavu

Идентификаторы

NCT: NCT07284095 · SANTE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗