Evaluating the effects of daily microgreen powder supplementation over 60 days on fatigue and nutrition-related symptoms among women of reproductive age in Yangon, Myanmar
ISRCTN | ISRCTN14209798 |
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DOI | https://doi.org/10.1186/ISRCTN14209798 |
Secondary identifying numbers | STI IRB/21/25 |
- Submission date
- 17/07/2025
- Registration date
- 18/07/2025
- Last edited
- 18/07/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many women in Myanmar struggle to get the nutrients they need due to rising food prices and limited access to healthy food. This often leads to fatigue, weakened immunity, and other symptoms of malnutrition. This study will test whether taking a small daily amount of microgreen powder, made from nutritious young plants like sunflower sprouts, over 60 days can help improve women’s health outcomes, especially by reducing fatigue and malnutrition and strengthening their bodies.
Who can participate?
Women aged 18 to 49 years who live in Hlaing Tharyar, are not pregnant, and are not already taking any supplements. Participants must also be at risk of poor nutrition, which we will assess using a short screening tool.
What does the study involve?
Women who join the study will be randomly placed into one of two groups. One group will take 10 grams of microgreen powder at the community centre each day for 60 days, while the other group will wait and receive the powder after the study ends. Everyone will come to a local community centre twice, once at the beginning and once at the end, for simple measurements of height and weight and to answer a few questions about their wellbeing. Nurses will support participants daily and check in on how they are doing.
What are the possible benefits and risks of participation?
Participants may feel more energetic and notice improvements in other health symptoms, like appetite or skin condition. There are no known serious risks, as the powder is made from natural, plant-based ingredients. Some people might feel mild stomach discomfort, but nurses will be on hand to help if needed.
Where is the study run from?
The study will take place at a community centre in Haling Tharyar township in Yangon, Myanmar.
When is the study starting and how long is it expected to run for?
November 2024 to October 2025
Who is funding the study?
This research is funded by the Pears IMPH Alumni Seed Grant Program to Promote Public Health Research, which is the result of a continuing partnership between the Braun School of Public Health, Hebrew University of Jerusalem Hadassah and Pears Foundation.
Who is the main contact?
Daniel Israel Samuelsen, israel@edenmyanmar.org
Contact information
Public, Scientific, Principal Investigator
97K Thanlwin Road
Kamaryut Township
Yangon
10-1191
Myanmar
0009-0002-5375-0596 | |
Phone | +95 (0)9694466755 |
israel@edenmyanmar.org |
Study information
Study design | Waitlist-controlled single-centre interventional trial using block randomisation with blinded outcome assessors |
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Primary study design | Interventional |
Secondary study design | Waitlist-controlled trial |
Study setting(s) | Community |
Study type | Prevention |
Participant information sheet | 47692_PIS_V1.2.pdf |
Scientific title | A waitlist-controlled trial evaluating the effects of daily supplementation with 10 g of microgreen powder over 60 days on malnutrition-related symptoms among women of reproductive age in Hlaing Tharyar, Yangon |
Study acronym | MICRO-WELL |
Study objectives | Hypotheses: 1. Daily supplementation with 10g of microgreen powder will significantly reduce fatigue (measured via Fatigue Severity Scale) among women of reproductive age over 60 days compared to a waitlist-control group. 2. Supplementation will improve BMI and malnutrition-related symptoms over 60 days in the intervention group. 3. Acceptability and satisfaction of the microgreen powder will be moderate to high. |
Ethics approval(s) |
Approved 01/07/2025, STI Myanmar University, Yangon; Institutional Review Board (Block 10, Phase 3 MICT Park, Hlaing Campus, Yangon, 10-3, Myanmar; +95 (0)1507048; info@stiedu.net), ref: STI IRB/21/25 |
Health condition(s) or problem(s) studied | Dietary micronutrient deficiency |
Intervention | Group A (intervention): Receives 10 g of microgreen powder daily, made from an equal blend of sunflower, mung bean and mustard seed, administered with water under nurse supervision at a community centre for 60 days. Group B (waitlist-control): Receives no intervention during the study but is given a 60-day supply of microgreen powder at study completion. Randomisation: Stratified block randomisation by malnutrition risk category (medium/high). The block order (4, 6, 8) was randomised using a computer-generated sequence in R software. |
Intervention type | Supplement |
Primary outcome measure | 1. Fatigue severity measured using the Fatigue Severity Scale (FSS) at baseline (T0) and day 60 (T1) 2. Body Mass Index (BMI) calculated from weight and height measurements using standard stadiometers and digital scales at baseline (T0) and day 60 (T1) 3. Malnutrition-related symptom severity measured using a structured Malnutrition Symptom Survey (Likert-scale) at baseline (T0) and day 60 (T1) |
Secondary outcome measures | Acceptability and satisfaction with supplementation measured using a structured post-intervention questionnaire at day 60 (T1) |
Overall study start date | 08/11/2024 |
Completion date | 31/10/2025 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 49 Years |
Sex | Female |
Target number of participants | 204 |
Key inclusion criteria | 1. Women aged 18-49 years 2. Resident of Hlaing Tharyar township 3. Malnutrition Universal Screening Tool score indicating medium or high malnutrition risk 4. Not currently pregnant 5. Not taking any other nutritional supplements 6. Able and willing to provide informed consent |
Key exclusion criteria | 1. Low malnutrition risk score using the Malnutrition Universal Screening Tool 2. Severe acute/chronic illness or allergy to supplement ingredients 3. Having chronic diarrhoea for more than 2 weeks in the past 1-3 months or having known malabsorption disorders 4. Currently in another study or trial |
Date of first enrolment | 20/08/2025 |
Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- Myanmar
Study participating centre
Ward 15, Hlaing Tharyar Township
Yangon
10-15
Myanmar
Sponsor information
University/education
School of Public Health
Faculty of Medicine
Jerusalem
91120
Israel
Phone | +972 (0)26777108 |
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maureenm@ekmd.huji.ac.il | |
Website | https://medicine.ekmd.huji.ac.il/en/publicHealth/about/Pages/contactUs.aspx |
https://ror.org/03qxff017 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Pears Family Charitable Foundation
- Location
- United Kingdom
No information available
Results and Publications
Intention to publish date | 31/10/2026 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Results will be shared with the participants, local relevant partners and stakeholders. The results will be submitted for publication in a peer-reviewed open-access journal and presented in international conferences. |
IPD sharing plan | The de-identified dataset will be securely stored on password-protected computers and a private Dropbox repository accessible only to authorised research team members. The data will be retained indefinitely for potential secondary analyses and to allow verification of study findings. Any data sharing will be strictly controlled, available only upon reasonable request to the Principal Investigator (Daniel Israel Samuelsen; israel@edenmyanmar.org) for ethically approved research purposes. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Participant information sheet | version 1.2 | 18/07/2025 | No | Yes |
Additional files
Editorial Notes
17/07/2025: Study's existence confirmed by STI Myanmar University, Yangon; Institutional Review Board.