Effect of Moringa Royal Jelly on the Nutritional Status and Cognitive Level of Adolescent Girls

NCT07037498 | Active Not Recruiting DMC

• 2 other identifiers: 2739/UN4.14.1/TP.01.02/2024Nutrition
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undernutrition; Anemia; Stunting; Cognitive Function 1, Social

Keywords

Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index-for-Age Z-score (BMI-for-age)

  Mean change in BMI-for-age z-scores as per WHO AnthroPlus standards, measured at baseline, 6 months, and 12 months.

  Baseline, 6 months, and 12 months

Secondary Outcomes (2)

• Change in Mid-Upper Arm Circumference (MUAC)

  Baseline, 6 months, and 12 months

• Change in cognitive function score (CFIT)

  Baseline and 12 months

Study Arms (2)

MRJ Supplementation Group

EXPERIMENTAL

Participants in this arm receive MRJ capsules containing 490 mg Moringa oleifera extract and 10 mg royal jelly, taken twice per week for 12 months. The supplementation is accompanied by standardized nutrition education delivered through TikTok videos. Adherence is monitored weekly via teacher-supervised log sheets and WhatsApp documentation.

Dietary Supplement: Moringa Oleifera

IFA Tablet Group (Control)

ACTIVE COMPARATOR

Participants in this arm receive weekly iron-folic acid (IFA) tablets according to national guidelines (60 mg elemental iron and 400 µg folic acid) for 12 months. They also receive the same standardized nutrition education via TikTok videos. Adherence is tracked using weekly log sheets verified by teachers and supported by WhatsApp photo submissions.

Dietary Supplement: Moringa Oleifera

Interventions

Moringa Oleifera DIETARY_SUPPLEMENT

Participants receive MRJ capsules containing 490 mg of Moringa oleifera leaf extract and 10 mg of royal jelly, taken orally twice per week for 12 months. The capsules are plant-based, produced using locally sourced ingredients, and are part of a food-based supplementation strategy developed as an alternative to iron-folic acid tablets. The intervention is combined with standardized nutrition education via TikTok videos. Adherence is monitored weekly through teacher log sheets and WhatsApp documentation. and Participants receive iron-folic acid (IFA) tablets containing 60 mg of elemental iron and 400 µg of folic acid, taken orally once per week for 12 months in accordance with Indonesia's national supplementation guidelines for adolescent girls. This control intervention is combined with the same standardized nutrition education via TikTok videos. Compliance is tracked weekly through teacher-supervised control sheets and WhatsApp photo submissions.

Also known as: Royal jelly, edukasi

IFA Tablet Group (Control); MRJ Supplementation Group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (1) Age 10-19 years (2) Adolescent girls' who are active in grades 1 and 2 (junior high and senior high)

You may not qualify if:

• (3) Severe nutritional or health conditions (e.g., severe anemia, severe malnutrition, allergies), determined through clinical histories and validated self-reports.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Schools under the supervision of Puskesmas Bonto Kassi, Galesong Selatan, Takalar District, South Sulawesi, Indonesia

Takalar, South Sulawesi, 92254, Indonesia

Location

Related Publications (1)

• 1. Patton GC, Sawyer SM, Santelli JS, et al. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016;387(10036):2423-78. 2. World Health Organization. Nutrition in adolescence: issues and challenges for the health sector. Geneva: WHO; 2005. 3. Black MM. Micronutrient deficiencies and cognitive functioning. J Nutr. 2003;133(11 Suppl 2):3927S-31S. 4. Best C, Neufingerl N, Van Geel L, van den Briel T, Osendarp S. The nutritional status of school-aged children: why should we care? Food Nutr Bull. 2010;31(3):400-17. 5. UNICEF. The State of the World's Children 2019: Children, food and nutrition. New York: UNICEF; 2019. 6. World Health Organization. Anaemia in women and children. Geneva: WHO; 2023. 7. Health Research and Development Agency. Basic Health Research 2018. Jakarta: Ministry of Health, Republic of Indonesia; 2018. 8. Ministry of Health of the Republic of Indonesia. Indonesia Health Profile 2023. Jakarta: MoH; 2024. 9. Dewey KG, Begum K. Long-term consequences of stunting in early life. Matern Child Nutr. 2011;7(Suppl 3):5-18. 10. Hadju V, Salmah AU, Natsir R, et al. Stunting and its risk factors among adolescent girls in South Sulawesi. Media Gizi Masyarakat Indonesia. 2020;5(2):59-66. 11. Walker SP, Chang SM, Powell CA, et al. Effects of early childhood psychosocial stimulation and nutritional supplementation on cognition and education in growth-stunted Jamaican children. Lancet. 2005;366(9499):1804-7. 12. Grantham-McGregor S, Cheung YB, Cueto S, et al. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007;369(9555):60-70. 13. Prentice AM, Ward KA, Goldberg GR, et al. Critical windows for nutritional interventions against stunting. Am J Clin Nutr. 2013;97(5):911-8. 14. Stoltzfus RJ. Iron deficiency: global prevalence and consequences. Food Nutr Bull. 2003;24(4 Suppl):S99-103. 15. Ministry of Health of the Republic of Indonesia. Indonesia Nutrition Status Survey (SSGI) 2023. Jakarta: MoH; 2024.

  RESULT

MeSH Terms

Conditions

Malnutrition; Anemia; Growth Disorders

Interventions

flocculant protein MO 2.1, Moringa oleifera; royal jelly

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Nutrition

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: February 10, 2025
• Primary Completion: June 10, 2025
• Study Completion: February 17, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified individual participant data (IPD) will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years thereafter.
• Access Criteria: Qualified researchers with a scientifically sound proposal may request access to the de-identified data. Access will be granted for purposes of academic research, meta-analysis, or systematic review. Requests should be submitted in writing to the principal investigator or sponsor institution and must include a data use agreement.

Locations

ID (1)