Effects of Moringa Oleifera and Royal Jelly Supplementation on Nutritional Status and Cognitive Function in Adolescent Girls in Takalar District, South Sulawesi, Indonesia: Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index-for-Age Z-score (BMI-for-age)
研究概览
简要总结
The goal of this clinical trial is to learn whether a locally developed supplement called MRJ - a combination of Moringa oleifera (drumstick tree) extract and royal jelly - can improve the nutritional status and cognitive function of adolescent girls more effectively than standard iron and folic acid (IFA) tablets.
The main questions it aims to answer are:
Does MRJ supplementation lead to better improvements in nutrition (e.g., hemoglobin, body measurements)?
Does MRJ supplementation enhance cognitive function compared to IFA tablets?
Researchers will compare MRJ capsules to IFA tablets (the standard of care) among adolescent girls.
Participants will:
Take 2 MRJ capsules per week (intervention group) or 1 IFA tablet per week (control group) for 12 months
Receive nutrition education via short TikTok-based videos
Have their adherence monitored weekly by teachers and through WhatsApp photos
Measurements will be taken at the start, 6 months, and 12 months, including:
Height, weight, and mid-upper arm circumference (MUAC)
Hemoglobin levels via finger-prick blood test
Dietary intake using a 24-hour recall and food frequency questionnaire (FFQ)
Cognitive function assessed with the Culture Fair Intelligence Test (CFIT)
Participants are healthy junior and senior high school girls aged 10-18 years from Galesong Selatan, Takalar District, South Sulawesi, Indonesia.
Potential side effects (e.g., nausea or stomach discomfort) will be monitored according to school health protocols.
The findings may support the use of culturally appropriate, nutrient-rich interventions for improving adolescent girls' health and future well-being.
详细描述
This clinical trial aims to evaluate whether a locally produced supplement, MRJ (a combination of Moringa oleifera extract and royal jelly), can improve nutritional status and cognitive function among adolescent girls in South Sulawesi, Indonesia, compared to the standard iron and folic acid (IFA) tablets provided by the government. If proven effective, MRJ may serve as a culturally acceptable and nutrient-rich alternative to support adolescent health and development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(1) Age 10-19 years (2) Adolescent girls' who are active in grades 1 and 2 (junior high and senior high)
排除标准
- •(3) Severe nutritional or health conditions (e.g., severe anemia, severe malnutrition, allergies), determined through clinical histories and validated self-reports.
结局指标
主要结局
Change in Body Mass Index-for-Age Z-score (BMI-for-age)
时间窗: Baseline, 6 months, and 12 months
Mean change in BMI-for-age z-scores as per WHO AnthroPlus standards, measured at baseline, 6 months, and 12 months.
次要结局
- Change in Mid-Upper Arm Circumference (MUAC)(Baseline, 6 months, and 12 months)
- Change in cognitive function score (CFIT)(Baseline and 12 months)
研究者
Musfira
Department Nutrition
Hasanuddin University