Skeletal and Cognitive Effects of Nutrition From Eggs

NCT03739424 | Completed

• 1 other identifier: 2521RC296228
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Health; Cognitive Health

Keywords

Bone; Cognition; Egg; Protein

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Serum Lipids

  Serum samples will be collected at baseline, 4.5 months and 9 months

• Insulin

  Serum samples will be collected at baseline, 4.5 months and 9 months

• Insulin like growth factor 1

  Serum samples will be collected at baseline, 4.5 months and 9 months

• Vascular endothelial growth factor

  Serum samples will be collected at baseline, 4.5 months and 9 months

• C-reactive protein

  Serum samples will be collected at baseline, 4.5 months and 9 months

Study Arms (3)

Whole egg powder arm

EXPERIMENTAL

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

Whole milk powder arm

ACTIVE COMPARATOR

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

Gelatin arm

PLACEBO COMPARATOR

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

Interventions

Whole egg powder OTHER

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 egg powder arm

Whole milk powder OTHER

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.

Whole milk powder arm

Gelatin food product OTHER

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.

Gelatin arm

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30606, United States

Location

Related Publications (5)

• 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.

  PMID: 23952203 RESULT

• 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.

  PMID: 24219608 RESULT

• 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.

  PMID: 23479546 RESULT

• 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.

  PMID: 23952200 RESULT

• 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.

  PMID: 36173384 DERIVED

Study Officials

• Richard D Lewis, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

• Nicole J Crenshaw

  University of Georgia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UGA Foundation Professor in Family and Consumer Sciences

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: April 28, 2018
• Primary Completion: July 11, 2020
• Study Completion: July 11, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

US (1)