Skeletal and Cognitive Effects of Nutrition From Eggs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Health, Cognitive Health

Intervention / Treatment
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* Other: Whole egg powder
* Other: Whole milk powder
* Other: Gelatin food product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole egg powder arm<br>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. | Other: Whole egg powder<br>* 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.<br>|
| Active Comparator: Whole milk powder arm<br>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. | Other: Whole milk powder<br>* 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.<br>|
| Placebo Comparator: Gelatin arm<br>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. | Other: Gelatin food product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Changes in cognitive function will be assessed from baseline to 4.5 and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lipids | Changes in serum lipids | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Insulin | Changes in serum insulin | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Insulin like growth factor 1 | Changes in insulin like growth factor 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Vascular endothelial growth factor | Changes in vascular endothelial growth factor | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| C-reactive protein | Changes in C-reactive protein | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Monocyte chemoattractant protein 1 | Changes in monocyte chemoattractant protein 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Interleukin 6 | Changes in interleukin 6 | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Tumor necrosis factor alpha | Changes in tumor necrosis factor alpha | Serum samples will be collected at baseline, 4.5 months and 9 months | 
| Glucose | Changes in glucose | Serum samples will be collected at baseline, 4.5 months and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone, Cognition, Egg, Protein