Skeletal and Cognitive Effects of Nutrition From Eggs

University of Georgia182 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

182

Conditions

Bone Health Cognitive Health

Interventions

Whole egg powderOTHER

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.

Whole milk powderOTHER

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.

Gelatin food productOTHER

Eligibility

Sex: ALLMin age: 9 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Georgia

Athens, Georgia, United States

Outcomes

Primary Outcomes

Bone Outcomes

Three-dimensional cortical and trabecular bone geometry measures will be assessed via pQCT at the tibia and radius. Outcome measures from the pQCT will include cortical and trabecular bone mineral density, cortical bone mineral area, total area, periosteal circumference, endosteal circumference, strength strain index, and bone strain index. DXA will be used to assess two-dimensional bone measurements at the lumbar spine, non-dominant hip, forearm, and total body.

Time frame: Assess changes in bone outcomes from baseline to 9 months

Body Composition

Body composition measures (i.e., total body fat mass, fat-free soft tissue mass, and percent body fat) will be assessed by DXA.

Time frame: Measure changes in body composition from baseline to 4.5 months and 9 months.

Cognitive Health

Cognitive health will be measured using the National Institute of Health's Toolbox. This toolbox for which validity evidence and national norms for children have been provided (Tulsky et al., 2013; Akshoomoff et al., 2014; Weintraub et al., 2013; Zelazo et al., 2013), will measure six cognitive domains: Executive Function, Episodic Memory, Working Memory, Attention, Language Ability, and Processing Speed.

Time frame: Changes in cognitive function will be assessed from baseline to 4.5 and 9 months

Secondary Outcomes

Serum Lipids

Changes in serum lipids

Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months

Insulin

Changes in serum insulin

Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months

Insulin like growth factor 1

Data from ClinicalTrials.gov

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