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

Malnutrition, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896996
• Other study ID #: 120/2560(EC2)
• Status: Completed
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: April 29, 2020

Study information

• Verified date: May 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: April 29, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Dietary Supplement:
• whole eggs
whole eggs
• yolk-free egg substitutes
yolk-free egg substitutes

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in body weight following the dietary intervention	weight (kg), weight for age (z-score) analysis	week 0 (baseline), week 13 - 14, week 34 - 35
Primary	changes in height following the dietary intervention	height (cm), height for age (z-score) analysis	week 0 (baseline), week 13 - 14, week 34 - 35
Primary	change in blood protein levels following dietary intervention	transferrin (mg/dl), pre-albumin (mg/dl), albumin (g/dl) analysis	week 0 (baseline), week 13 - 14, week 34 - 35
Primary	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)	week 0 (baseline), week 13 - 14, week 34 - 35
Secondary	changes in microbioma and stool metabolites following dietary intervention	bacterial type, fatty acids in stool	week 0 (baseline), week 13 - 14, week 34 - 35
Secondary	changes in blood biochemistries following dietary intervention metabolite enzyme	lecithin-cholesterol acyltransferase (LCAT), cholesterol ester transfer protein (CETP), apolipoprotein C (APOC), apolipoprotein E (APOE)	week 0 (baseline), week 13 - 14, week 34 - 35