Skeletal and Cognitive Effects of Nutrition From Eggs (SCENE)

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Health; Cognitive Health
• Intervention / Treatment: Other: Whole egg powder; Other: Whole milk powder; Other: Gelatin food product

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30606
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole egg powder arm; 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; 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.
Active Comparator: Whole milk powder arm; 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; 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.
Placebo Comparator: Gelatin arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Egg Nutrition Center
• Investigators: Principal Investigator: Richard D Lewis, PhD, University of Georgia; Study Director: Nicole J Crenshaw, University of Georgia

Publications and helpful links

General Publications

• 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.
• 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 Cognition Battery: results from a large normative developmental sample (PING). Neuropsychology. 2014 Jan;28(1):1-10. doi: 10.1037/neu0000001. Epub 2013 Nov 11. Erratum In: Neuropsychology. 2014 Mar;28(2):319.
• 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 L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
• 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.
• O'Connor PJ, Chen X, Coheley LM, Yu M, Laing EM, Oshri A, Marand A, Lance J, Kealey K, Lewis RD. The effects of 9 months of formulated whole-egg or milk powder food products as meal or snack replacements on executive function in preadolescents: A randomized, placebo-controlled trial. Am J Clin Nutr. 2022 Dec 19;116(6):1663-1671. doi: 10.1093/ajcn/nqac281.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2018
• Primary Completion (Actual): July 11, 2020
• Study Completion (Actual): July 11, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Bone; Cognition; Protein; Egg
• Other Study ID Numbers: 2521RC296228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No