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

NCT ID: NCT04896996

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-21

Study Completion Date

2020-04-29

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.

Conditions

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Malnutrition, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled cluster trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Whole eggs (WE)

consume 10 additional eggs per week

Group Type EXPERIMENTAL

whole eggs

Intervention Type DIETARY_SUPPLEMENT

whole eggs

Egg substitute (ES)

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

Group Type EXPERIMENTAL

yolk-free egg substitutes

Intervention Type DIETARY_SUPPLEMENT

yolk-free egg substitutes

Control group

Regular school meals

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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whole eggs

whole eggs

Intervention Type DIETARY_SUPPLEMENT

yolk-free egg substitutes

yolk-free egg substitutes

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophida Suta, MS.

Role: STUDY_DIRECTOR

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

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 20420104 (View on PubMed)

Other Identifiers

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120/2560(EC2)

Identifier Type: -

Identifier Source: org_study_id

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