UndernutritionMRJNCT07037498
Effect of Moringa Royal Jelly on the Nutritional Status and Cognitive Level of Adolescent Girls
A study testing Moringa Oleifera in people with Undernutrition and Anemia, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Anemia, Stunting
- What is being tested?
- Moringa Oleifera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Feb 2025to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (1) Age 10-19 years (2) Adolescent girls' who are active in grades 1 and 2 (junior high and senior high)
Who cannot join
- (3) Severe nutritional or health conditions (e.g., severe anemia, severe malnutrition, allergies), determined through clinical histories and validated self-reports.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Schools under the supervision of Puskesmas Bonto Kassi, Galesong Selatan, Takalar District, South Sulawesi, Indonesia
Takalar, South Sulawesi, 92254
About this study
Official title: 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
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Undernutrition, Anemia, Stunting, Cognitive Function 1, Social
- Being tested
- Moringa Oleifera
- Keywords
- Nutrition
- Medical subject headings
- Malnutrition, Anemia, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa OleiferaDietary supplement
Also called Royal jelly, edukasi
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Moringa Oleifera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (2)
Change in Mid-Upper Arm Circumference (MUAC)
Mean change in mid-upper arm circumference (cm) measured using standard non-stretchable tape.
Measured: Baseline, 6 months, and 12 months
Change in cognitive function score (CFIT)
Change in cognitive function as assessed using the Culture Fair Intelligence Test (CFIT) at baseline and 12 months.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start10 Feb 2025
- Primary completion10 Jun 2025
- Study completion17 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musfira, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037498
- Sponsor's protocol ID
- 2739/UN4.14.1/TP.01.02/2024
- Other IDs
- Nutrition
- Acronym
- MRJ
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that will be shared include de-identified data on anthropometric measures (BMI-for-age, height-for-age, MUAC), hemoglobin levels, dietary intake (24-hour recall and FFQ), and cognitive function scores (CFIT results). All shared data will be anonymized and stripped of any personal identifiers.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07037498
- Acronym / sponsor ID
- MRJ / 2739/UN4.14.1/TP.01.02/2024
- Conditions
- Undernutrition, Anemia, Stunting, Cognitive Function 1, Social
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 17 Feb 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRJ Supplementation Group | Experimental | Dietary Supplement: Moringa OleiferaParticipants 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. |
| IFA Tablet Group (Control) | Active comparator | Dietary Supplement: Moringa OleiferaParticipants 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- (1) Age 10-19 years (2) Adolescent girls' who are active in grades 1 and 2 (junior high and senior high)
Key exclusion criteria (1 listed)
- (3) Severe nutritional or health conditions (e.g., severe anemia, severe malnutrition, allergies), determined through clinical histories and validated self-reports.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa OleiferaAlso: Royal jelly, edukasiParticipants 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. | Dietary supplement | IFA Tablet Group (Control), MRJ Supplementation Group |
Primary outcome
Change in Body Mass Index-for-Age Z-score (BMI-for-age)
Time frame: 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.
2 secondary outcomes
Change in Mid-Upper Arm Circumference (MUAC)
Time frame: Baseline, 6 months, and 12 months
Change in cognitive function score (CFIT)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Results publication1. 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that will be shared include de-identified data on anthropometric measures (BMI-for-age, height-for-age, MUAC), hemoglobin levels, dietary intake (24-hour recall and FFQ), and cognitive function scores (CFIT results). All shared data will be anonymized and stripped of any personal identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa Oleifera in people with Undernutrition and Anemia, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index-for-Age Z-score (BMI-for-age) (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07037498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.