The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)

Conditions
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Malnutrition, Child

Intervention / Treatment
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* Dietary Supplement: whole eggs
* Dietary Supplement: yolk-free egg substitutes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Aged between 8-14 years Exclusion Criteria: Allergic of eggs People who cannot continue to follow up the protocol 4. Having contra-indication i.e. problems with blood clotting

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled cluster trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole eggs (WE)<br>consume 10 additional eggs per week | Dietary Supplement: whole eggs<br>* whole eggs<br>|
| Experimental: Egg substitute (ES)<br>consume the yolk-free egg substitute equivalent to 10 eggs per week | Dietary Supplement: yolk-free egg substitutes<br>* yolk-free egg substitutes<br>|
| No Intervention: Control group<br>Regular school meals | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in body weight following the dietary intervention | weight (kg), weight for age (z-score) analysis | week 0 (baseline), week 13 - 14, week 34 - 35 | 
| changes in height following the dietary intervention | height (cm), height for age (z-score) analysis | 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 | 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) | week 0 (baseline), week 13 - 14, week 34 - 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in microbioma and stool metabolites following dietary intervention | bacterial type, fatty acids in stool | 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) | week 0 (baseline), week 13 - 14, week 34 - 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, whole egg consumption, primary school student, growth