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

Primary Purpose

Malnutrition, Child

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

whole eggs

yolk-free egg substitutes

About this trial

This is an interventional basic science trial for Malnutrition, Child focused on measuring malnutrition, whole egg consumption, primary school student, growth

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Whole eggs (WE)

Egg substitute (ES)

Control group

Arm Description

consume 10 additional eggs per week

consume the yolk-free egg substitute equivalent to 10 eggs per week

Regular school meals

Outcomes

Primary Outcome Measures

changes in body weight following the dietary intervention

weight (kg), weight for age (z-score) analysis

changes in height following the dietary intervention

height (cm), height for age (z-score) analysis

change in blood protein levels following dietary intervention

transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis

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)

Secondary Outcome Measures

changes in microbioma and stool metabolites following dietary intervention

bacterial type, fatty acids in stool

changes in blood biochemistries following dietary intervention metabolite enzyme

lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)

Full Information

NCT ID

NCT04896996

First Posted

May 18, 2021

Last Updated

May 18, 2021

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT04896996

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

May 21, 2019 (Actual)

Primary Completion Date

February 26, 2020 (Actual)

Study Completion Date

April 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition, Child

Keywords

malnutrition, whole egg consumption, primary school student, growth

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomized controlled cluster trial

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

635 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole eggs (WE)

Arm Type

Experimental

Arm Description

consume 10 additional eggs per week

Arm Title

Egg substitute (ES)

Arm Type

Experimental

Arm Description

consume the yolk-free egg substitute equivalent to 10 eggs per week

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Regular school meals

Intervention Type

Dietary Supplement

Intervention Name(s)

whole eggs

Intervention Description

whole eggs

Intervention Type

Dietary Supplement

Intervention Name(s)

yolk-free egg substitutes

Intervention Description

yolk-free egg substitutes

Primary Outcome Measure Information:

Title

changes in body weight following the dietary intervention

Description

weight (kg), weight for age (z-score) analysis

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

Title

changes in height following the dietary intervention

Description

height (cm), height for age (z-score) analysis

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

Title

change in blood protein levels following dietary intervention

Description

transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

Title

changes in blood biochemistries following dietary intervention

Description

fasting blood sugar (mg/dl), cholesterol (mg/dl), triglyceride (mg/dl), HDL-Cholesterol (mg/dl), LDL-Cholesterol (mg/dl)

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

Secondary Outcome Measure Information:

Title

changes in microbioma and stool metabolites following dietary intervention

Description

bacterial type, fatty acids in stool

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

Title

changes in blood biochemistries following dietary intervention metabolite enzyme

Description

lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)

Time Frame

week 0 (baseline), week 13 - 14, week 34 - 35

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophida Suta, MS.

Organizational Affiliation

Population Health and Nutrition Research Group, Siriraj Hospital, Mahidol University, Thailand

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital, Mahidol University

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20420104

Citation

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.

Results Reference

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Learn more about this trial

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

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