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

Not Applicable

Completed

• Conditions: Malnutrition, Child
• Interventions: Dietary Supplement: whole eggs; Dietary Supplement: yolk-free egg substitutes

• Registration Number: NCT04896996
• Lead Sponsor: Mahidol University

Brief 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.

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 Timeline

• Study Start: 2019-05-21
• Primary Completion: 2020-02-26
• Study Completion: 2020-04-29
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 635

Inclusion Criteria

1. Aged between 8-14 years

Exclusion Criteria

1. Allergic of eggs

2. People who cannot continue to follow up the protocol

3. Having contra-indication i.e. problems with blood clotting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole eggs (WE)	whole eggs	consume 10 additional eggs per week
Egg substitute (ES)	yolk-free egg substitutes	consume the yolk-free egg substitute equivalent to 10 eggs per week

Primary Outcome Measures

Name	Time	Method
change in blood protein levels following dietary intervention	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	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)
changes in height following the dietary intervention	week 0 (baseline), week 13 - 14, week 34 - 35	height (cm), height for age (z-score) analysis
changes in body weight following the dietary intervention	week 0 (baseline), week 13 - 14, week 34 - 35	weight (kg), weight for age (z-score) analysis

Secondary Outcome Measures

Name	Time	Method
changes in microbioma and stool metabolites following dietary intervention	week 0 (baseline), week 13 - 14, week 34 - 35	bacterial type, fatty acids in stool
changes in blood biochemistries following dietary intervention metabolite enzyme	week 0 (baseline), week 13 - 14, week 34 - 35	lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand