Skeletal and Cognitive Effects of Nutrition From Eggs
- Conditions
- Bone HealthCognitive Health
- Interventions
- Other: Whole milk powderOther: Whole egg powderOther: Gelatin food product
- Registration Number
- NCT03739424
- Lead Sponsor
- University of Georgia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Whole milk powder arm Whole milk powder 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. Whole egg powder arm Whole egg powder 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. Gelatin arm Gelatin food product 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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
Insulin Serum samples will be collected at baseline, 4.5 months and 9 months Changes in serum insulin
Serum Lipids Serum samples will be collected at baseline, 4.5 months and 9 months Changes in serum lipids
Glucose Serum samples will be collected at baseline, 4.5 months and 9 months Changes in glucose
Trial Locations
- Locations (1)
University of Georgia
🇺🇸Athens, Georgia, United States