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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03739424
Other study ID # 2521RC296228
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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