Clinical trial NCT03739424: Skeletal and Cognitive Effects of Nutrition From Eggs
Official title: Egg Consumption, Skeletal Health, and Cognition in Normal Weight and Obese Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Health
Cognitive Health
Keywords: Bone
Cognition
Egg
Protein
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2018-11-13
Enrollment: 182
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone Outcomes
timeFrame: Assess changes in bone outcomes from baseline to 9 months
measure: Body Composition
timeFrame: Measure changes in body composition from baseline to 4.5 months and 9 months.
measure: Cognitive Health
timeFrame: Changes in cognitive function will be assessed from baseline to 4.5 and 9 months
Secondary outcomes:
measure: Serum Lipids
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Insulin
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Insulin like growth factor 1
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Vascular endothelial growth factor
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: C-reactive protein
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Monocyte chemoattractant protein 1
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Interleukin 6
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Tumor necrosis factor alpha
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
measure: Glucose
timeFrame: Serum samples will be collected at baseline, 4.5 months and 9 months
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Richard D Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Nicole J Crenshaw
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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 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.
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.
citation: 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.