Skeletal and Cognitive Effects of Nutrition From Eggs (SCENE)

University of Georgia (UGA)

Status: Completed

Conditions: Bone Health; Cognitive Health

Treatments: Other: Whole milk powder; Other: Gelatin food product; Other: Whole egg powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03739424

2521RC296228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apparently healthy and well-nourished
• White, Black or Hispanic
• Males and females between the chronological ages of 9-13 years
• Sexual maturation rating, as measured by Tanner, at stages 2/3.
• Must be willing to provide a blood sample
• Not allergic to egg or egg products, milk or milk products, or gelatin

Exclusion criteria

• Achievement of menarche (females)
• Sexual maturation rating, as measured by Tanner, at stages 4/5
• Known bone disease or disease know to influence bone metabolism (e.g., cerebral palsy, intestinal malabsorption, juvenile rheumatoid arthritis)
• Known growth disorders
• The use of medications that may influence bone metabolism (e.g., corticosteroids, attention-deficit/hyperactivity disorder medications)
• Allergic to egg or egg products, milk or milk products, or gelatin

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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182 participants in 3 patient groups, including a placebo group

Whole egg powder arm

Experimental group

Description:

The whole egg powder arm will be part of our food product intervention. Food products created using whole egg powder will be provided and consumed 10x/week for 9 months. Each food item will contain the equivalent of one whole egg.

Treatment:

Other: Whole egg powder

Whole milk powder arm

Active Comparator group

Description:

The whole milk powder arm will be part of our food product intervention. Food products created using whole milk powder will be provided and consumed 10x/week for 9 months. These items will have the equivalent amount of protein as the whole egg group. They will be isocaloric in nature.

Treatment:

Other: Whole milk powder

Gelatin arm

Placebo Comparator group

Description:

The gelatin food products will be a part of our food product intervention. Food products created using gelatin will be provided and consumed 10x/week for 9 months. These items will be isocaloric in nature to the other treatment arms but will not contain additional protein.

Treatment:

Other: Gelatin food product