A New Measure of Egg Consumption and the Effect of Social Marketing Eggs

Nutritional Stunting Clinical Trial

Official title:

A Two-Phase Study to Investigate Novel Biomarkers of Egg Consumption and Social Marketing Effectiveness of Egg Hubs for Malawian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461106
• Other study ID #: 202007077
• Status: Completed
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. Children will provide a urine sample for analysis of metabolites to correlate with egg consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: September 10, 2022
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Health children between 6 and 24 months of age

Exclusion Criteria:

• acute malnutrition

• congenital abnormalities

• chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection

Related Conditions & MeSH terms

• Growth Disorders
• Nutritional Stunting

Intervention

Other:
• Social Marketing Campaign
aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women

Locations

Country	Name	City	State
Malawi	Project Peanut Butter	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Kamuzu University of Health Sciences, Project Peanut Butter, Malawi

Country where clinical trial is conducted

Malawi, 

References & Publications (4)

Eaton JC, Rothpletz-Puglia P, Dreker MR, Iannotti L, Lutter C, Kaganda J, Rayco-Solon P. Effectiveness of provision of animal-source foods for supporting optimal growth and development in children 6 to 59 months of age. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD012818. doi: 10.1002/14651858.CD012818.pub2. — View Citation

Garcia-Perez I, Posma JM, Gibson R, Chambers ES, Hansen TH, Vestergaard H, Hansen T, Beckmann M, Pedersen O, Elliott P, Stamler J, Nicholson JK, Draper J, Mathers JC, Holmes E, Frost G. Objective assessment of dietary patterns by use of metabolic phenotyping: a randomised, controlled, crossover trial. Lancet Diabetes Endocrinol. 2017 Mar;5(3):184-195. doi: 10.1016/S2213-8587(16)30419-3. Epub 2017 Jan 13. — View Citation

Koppmair S, Kassie M, Qaim M. Farm production, market access and dietary diversity in Malawi. Public Health Nutr. 2017 Feb;20(2):325-335. doi: 10.1017/S1368980016002135. Epub 2016 Sep 9. — View Citation

S C Sri Harsha P, Abdul Wahab R, Cuparencu C, Dragsted LO, Brennan L. A Metabolomics Approach to the Identification of Urinary Biomarkers of Pea Intake. Nutrients. 2018 Dec 4;10(12):1911. doi: 10.3390/nu10121911. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of egg consumed daily	As determined by urinary metabolite concentrations. The specific metabolites will be identified in the course of the study.	12 Months