NCT03739424

Skeletal and Cognitive Effects of Nutrition From Eggs

Egg Consumption, Skeletal Health, and Cognition in Normal Weight and Obese Children: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: University of Georgia · Academic / Other
• Sex: All
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

Summary

This project is the first egg feeding randomized controlled trial (RCT) in children. The goal of this RCT is to determine if eating formulated whole egg products for 9 months improves bone health and cognitive function in children ages 9-13 years more than children consuming products made of milk powder or gelatin.

Detailed description

This 9-month randomized controlled trial is an egg product intervention in otherwise healthy, 9-13 year-old children in the early stages of puberty (N=120). It will assess changes in bone material and geometric properties using dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). Cognitive function will be measured by the National Institute of Health's Toolbox. Participants will be randomized to one of 3 treatment (i.e., whole egg powder, whole milk powder, or gelatin) groups, and instructed to consume the food projects 10 times/week in substitute for other similar food products in their diet for 9-months. Five product choices per treatment group will be provided. The food products were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization center and consumer tested. Additionally, these food products will be micro-tested prior to distribution to participants. We hypothesize that children consuming whole egg products will have enhanced bone outcomes and cognitive abilities in comparison to those consuming whole milk powder or gelatin.

Conditions

• Bone Health
• Cognitive Health

Interventions

Type	Name	Description
OTHER	Whole egg powder	Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with whole egg powder. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.
OTHER	Whole milk powder	Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with whole milk powder. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.
OTHER	Gelatin food product	Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with gelatin. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.

Timeline

• Start date: 2018-04-28
• Primary completion: 2020-07-11
• Completion: 2020-07-11
• First posted: 2018-11-13
• Last updated: 2020-11-03

Locations

1 site across 1 country: United States