SANTE INITIATIVE: Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prealbumin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Children with severe acute illnesses that may interfere with the intervention.
- •Children with known allergies to the ingredients of the nutritional products provided.
结局指标
主要结局
Prealbumin
时间窗: Baseline (Week 0) and 24 weeks of supplementation.
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)
时间窗: Baseline, 12 weeks and 24 weeks
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
次要结局
- Change in Serum Calcium Concentration (mg/dL)(From Baseline to 24 Weeks)
- Change in Serum Vitamin A Concentration (µg/dL)(From Baseline to 24 Weeks)
- Change in Serum Iron Concentration (µg/dL)(From Baseline to 24 Weeks)
- Change in Serum Zinc Concentration (µg/dL)(From Baseline to 24 Weeks)
- Change in Serum Vitamin B12 Concentration (pg/mL)(From Baseline to 24 Weeks)
- Change in Serum Vitamin B9 (Folate) Concentration (µg/dL)(From Baseline to 24 Weeks)
- Change in Serum Magnesium Concentration (mg/dL)(From Baseline to 24 Weeks)