Malnutrition, ChildNCT04896996
The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
A study testing whole eggs and yolk-free egg substitutes in people with Malnutrition, Child, run by Mahidol University at 1 site in Thailand.
Trial summary
This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- whole eggs and yolk-free egg substitutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 1 siteThailand
- Study dates
- 21 May 2019to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Aged between 8-14 years
Who cannot join
- Allergic of eggs
- People who cannot continue to follow up the protocol
- 4. Having contra-indication i.e. problems with blood clotting
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.
Read the detailed description
This research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.
- Conditions
- Malnutrition, Child
- Being tested
- whole eggs, yolk-free egg substitutes
- Keywords
- malnutrition, whole egg consumption, primary school student, growth
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole eggsDietary supplement
whole eggs
yolk-free egg substitutesDietary supplement
yolk-free egg substitutes
| Study group | Role | What they receive |
|---|---|---|
| Whole eggs (WE) | Experimental | consume 10 additional eggs per week Receives: Dietary Supplement: whole eggs |
| Egg substitute (ES) | Experimental | consume the yolk-free egg substitute equivalent to 10 eggs per week Receives: Dietary Supplement: yolk-free egg substitutes |
| Control group | No intervention | Regular school meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body weight following the dietary intervention
weight (kg), weight for age (z-score) analysis
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
changes in height following the dietary intervention
height (cm), height for age (z-score) analysis
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
change in blood protein levels following dietary intervention
transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
changes in blood biochemistries following dietary intervention
fasting blood sugar (mg/dl), cholesterol (mg/dl), triglyceride (mg/dl), HDL-Cholesterol (mg/dl), LDL-Cholesterol (mg/dl)
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
Secondary outcomes (2)
changes in microbioma and stool metabolites following dietary intervention
bacterial type, fatty acids in stool
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
changes in blood biochemistries following dietary intervention metabolite enzyme
lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)
Measured: week 0 (baseline), week 13 - 14, week 34 - 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start21 May 2019
- Primary completion26 Feb 2020
- Study completion29 Apr 2020
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 Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled cluster trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophida Suta, MS., Study director, Population Health and Nutrition Research Group, Siriraj Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896996
- Sponsor's protocol ID
- 120/2560(EC2)
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayurasakorn K, Sitphahul P, Hongto PO. Supplement of three eggs a week improves protein malnutrition in Thai children from rural areas. J Med Assoc Thai. 2010 Mar;93(3):301-9.
PubMed 20420104
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
- ClinicalTrials.gov ID
- NCT04896996
- Acronym / sponsor ID
- 120/2560(EC2)
- Conditions
- Malnutrition, Child
- Keywords
- malnutrition, whole egg consumption, primary school student, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 21 May 2021 (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.
This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.
Detailed description
This research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled cluster trial
| Arm | Type | Receives |
|---|---|---|
| Whole eggs (WE) | Experimental | Dietary Supplement: whole eggsconsume 10 additional eggs per week |
| Egg substitute (ES) | Experimental | Dietary Supplement: yolk-free egg substitutesconsume the yolk-free egg substitute equivalent to 10 eggs per week |
| Control group | No intervention | –Regular school meals |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Aged between 8-14 years
Key exclusion criteria (3 listed)
- Allergic of eggs
- People who cannot continue to follow up the protocol
- 4. Having contra-indication i.e. problems with blood clotting
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 |
|---|---|---|
| whole eggswhole eggs | Dietary supplement | Whole eggs (WE) |
| yolk-free egg substitutesyolk-free egg substitutes | Dietary supplement | Egg substitute (ES) |
Primary outcome
changes in body weight following the dietary intervention
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
weight (kg), weight for age (z-score) analysis
changes in height following the dietary intervention
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
height (cm), height for age (z-score) analysis
change in blood protein levels following dietary intervention
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis
changes in blood biochemistries following dietary intervention
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
fasting blood sugar (mg/dl), cholesterol (mg/dl), triglyceride (mg/dl), HDL-Cholesterol (mg/dl), LDL-Cholesterol (mg/dl)
2 secondary outcomes
changes in microbioma and stool metabolites following dietary intervention
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
changes in blood biochemistries following dietary intervention metabolite enzyme
Time frame: week 0 (baseline), week 13 - 14, week 34 - 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 20420104Mayurasakorn K, Sitphahul P, Hongto PO. Supplement of three eggs a week improves protein malnutrition in Thai children from rural areas. J Med Assoc Thai. 2010 Mar;93(3):301-9.
- Individual participant dataSharing planned: No
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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.
Sophida Suta, MS. study director
Population Health and Nutrition Research Group, Siriraj Hospital, Mahidol University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole eggs and yolk-free egg substitutes in people with Malnutrition, Child, run by Mahidol University at 1 site in Thailand.
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 3 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: finished, as of the sponsor's last update on 21 May 2021. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in body weight following the dietary intervention (time frame: week 0 (baseline), week 13 - 14, week 34 - 35). The study lists 4 primary outcomes in all. 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 NCT04896996, 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 21 May 2021.