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

NCT04896996 | Completed

• 1 other identifier: 120/2560(EC2)
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child

Keywords

malnutrition; whole egg consumption; primary school student; growth

Outcome Measures

Primary Outcomes (4)

• 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

• changes in height following the dietary intervention

  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

  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

  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 Outcomes (2)

• changes in microbioma and stool metabolites following dietary intervention

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

• changes in blood biochemistries following dietary intervention metabolite enzyme

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

Study Arms (3)

Whole eggs (WE)

EXPERIMENTAL

consume 10 additional eggs per week

Dietary Supplement: whole eggs

Egg substitute (ES)

EXPERIMENTAL

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

Dietary Supplement: yolk-free egg substitutes

Control group

NO INTERVENTION

Regular school meals

Interventions

whole eggs DIETARY_SUPPLEMENT

whole eggs

Whole eggs (WE)

yolk-free egg substitutes DIETARY_SUPPLEMENT

yolk-free egg substitutes

Egg substitute (ES)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Aged between 8-14 years

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related 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.

  PMID: 20420104 BACKGROUND

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sophida Suta, MS.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled cluster trial

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 21, 2019
• Primary Completion: February 26, 2020
• Study Completion: April 29, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)