Bone Health, Cognitive Health
Conditions
Keywords
Bone, Cognition, Egg, Protein
Brief 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.
Interventions
OTHERWhole 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.
OTHERWhole 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.
OTHERGelatin 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.
Sponsors
Egg Nutrition Center
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Outcomes | Assess changes in bone outcomes from baseline to 9 months | 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. |
| Body Composition | Measure changes in body composition from baseline to 4.5 months and 9 months. | Body composition measures (i.e., total body fat mass, fat-free soft tissue mass, and percent body fat) will be assessed by DXA. |
| Cognitive Health | Changes in cognitive function will be assessed from baseline to 4.5 and 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Lipids | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in serum lipids |
| Insulin | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in serum insulin |
| Insulin like growth factor 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in insulin like growth factor 1 |
| Vascular endothelial growth factor | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in vascular endothelial growth factor |
| C-reactive protein | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in C-reactive protein |
| Monocyte chemoattractant protein 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in monocyte chemoattractant protein 1 |
| Interleukin 6 | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in interleukin 6 |
| Tumor necrosis factor alpha | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in tumor necrosis factor alpha |
| Glucose | Serum samples will be collected at baseline, 4.5 months and 9 months | Changes in glucose |
Countries
United States
Outcome results
None listed