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
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Mr Daniel Israel Samuelsen
Public, Scientific, Principal Investigator

97K Thanlwin Road
Kamaryut Township
Yangon
10-1191
Myanmar

ORCiD logoORCID ID 0009-0002-5375-0596
Phone +95 (0)9694466755
Email israel@edenmyanmar.org

Study information

Study designWaitlist-controlled single-centre interventional trial using block randomisation with blinded outcome assessors
Primary study designInterventional
Secondary study designWaitlist-controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet 47692_PIS_V1.2.pdf
Scientific titleA 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 acronymMICRO-WELL
Study objectivesHypotheses:
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) studiedDietary micronutrient deficiency
InterventionGroup 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 typeSupplement
Primary outcome measure1. 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 measuresAcceptability and satisfaction with supplementation measured using a structured post-intervention questionnaire at day 60 (T1)
Overall study start date08/11/2024
Completion date31/10/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit49 Years
SexFemale
Target number of participants204
Key inclusion criteria1. 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 criteria1. 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 enrolment20/08/2025
Date of final enrolment31/08/2025

Locations

Countries of recruitment

  • Myanmar

Study participating centre

New Hope Myanmar Local NGO
New Hope NGO Community Center
Ward 15, Hlaing Tharyar Township
Yangon
10-15
Myanmar

Sponsor information

Hebrew University of Jerusalem
University/education

School of Public Health
Faculty of Medicine
Jerusalem
91120
Israel

Phone +972 (0)26777108
Email maureenm@ekmd.huji.ac.il
Website https://medicine.ekmd.huji.ac.il/en/publicHealth/about/Pages/contactUs.aspx
ROR logo "ROR" https://ror.org/03qxff017

Funders

Funder type

Charity

Pears Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Pears Family Charitable Foundation
Location
United Kingdom
Good Seed Myanmar

No information available

Results and Publications

Intention to publish date31/10/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults 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 planThe 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?
Participant information sheet version 1.2 18/07/2025 No Yes

Additional files

47692_PIS_V1.2.pdf

Editorial Notes

17/07/2025: Study's existence confirmed by STI Myanmar University, Yangon; Institutional Review Board.