Skeletal and Cognitive Effects of Nutrition From Eggs

Bone Health Clinical Trial

— SCENE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739424
• Other study ID #: 2521RC296228
• Status: Completed
• Phase: N/A
• Start date: April 28, 2018
• Est. completion date: July 11, 2020

Study information

• Verified date: November 2020
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 11, 2020
• Est. primary completion date: July 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Health
• Cognitive Health

Intervention

Other:
• Whole 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.
• Whole 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.
• Gelatin 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.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Akshoomoff N, Newman E, Thompson WK, McCabe C, Bloss CS, Chang L, Amaral DG, Casey BJ, Ernst TM, Frazier JA, Gruen JR, Kaufmann WE, Kenet T, Kennedy DN, Libiger O, Mostofsky S, Murray SS, Sowell ER, Schork N, Dale AM, Jernigan TL. The NIH Toolbox Cognitio — View Citation

Tulsky DS, Carlozzi NE, Chevalier N, Espy KA, Beaumont JL, Mungas D. V. NIH Toolbox Cognition Battery (CB): measuring working memory. Monogr Soc Res Child Dev. 2013 Aug;78(4):70-87. doi: 10.1111/mono.12035. — View Citation

Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund — View Citation

Zelazo PD, Anderson JE, Richler J, Wallner-Allen K, Beaumont JL, Weintraub S. II. NIH Toolbox Cognition Battery (CB): measuring executive function and attention. Monogr Soc Res Child Dev. 2013 Aug;78(4):16-33. doi: 10.1111/mono.12032. — View Citation

Outcome

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