Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
182 participants
INTERVENTIONAL
2018-04-28
2020-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
DOUBLE
Study Groups
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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.
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 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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
9 Years
13 Years
ALL
Yes
Sponsors
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Egg Nutrition Center
OTHER
University of Georgia
OTHER
Responsible Party
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Dr. Richard D. Lewis
UGA Foundation Professor in Family and Consumer Sciences
Principal Investigators
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Richard D Lewis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Georgia
Nicole J Crenshaw
Role: STUDY_DIRECTOR
University of Georgia
Locations
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University of Georgia
Athens, Georgia, United States
Countries
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References
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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.
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.
Other Identifiers
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2521RC296228
Identifier Type: -
Identifier Source: org_study_id