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Completed

NCT Number: NCT04896996

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

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.

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 8-14 years

Exclusion criteria

  • Allergic of eggs
  • People who cannot continue to follow up the protocol
  • Having contra-indication i.e. problems with blood clotting

Treatment and study plan

whole eggs

Dietary Supplement

whole eggs

yolk-free egg substitutes

Dietary Supplement

yolk-free egg substitutes

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 21, 2021
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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