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

May 18, 2021 updated by: Mahidol University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

635

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Aged between 8-14 years

Exclusion Criteria:

  1. Allergic of eggs
  2. People who cannot continue to follow up the protocol

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 0 (baseline), week 13 - 14, week 34 - 35
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
week 0 (baseline), week 13 - 14, week 34 - 35
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
week 0 (baseline), week 13 - 14, week 34 - 35
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)
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
Time Frame: week 0 (baseline), week 13 - 14, week 34 - 35
bacterial type, fatty acids in stool
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
lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)
week 0 (baseline), week 13 - 14, week 34 - 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Sophida Suta, MS., Population Health and Nutrition Research Group, Siriraj Hospital, Mahidol University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Actual)

February 26, 2020

Study Completion (Actual)

April 29, 2020

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120/2560(EC2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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