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Completed

NCT Number: NCT03739424

Skeletal and Cognitive Effects of Nutrition From Eggs

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.

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Key information

Conditions

Bone Health Cognitive Health

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. Bone Outcomes

    Time frame: Assess changes in bone outcomes from baseline to 9 months

    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.

  2. Body Composition

    Time frame: Measure changes in body composition from baseline to 4.5 months and 9 months.

    Body composition measures (i.e., total body fat mass, fat-free soft tissue mass, and percent body fat) will be assessed by DXA.

  3. Cognitive Health

    Time frame: Changes in cognitive function will be assessed from baseline to 4.5 and 9 months

    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.

Secondary outcomes

  1. Serum Lipids

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

    Changes in serum lipids

  2. Insulin

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

    Changes in serum insulin

  3. Insulin like growth factor 1

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

    Changes in insulin like growth factor 1

  4. Vascular endothelial growth factor

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

    Changes in vascular endothelial growth factor

  5. C-reactive protein

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

    Changes in C-reactive protein

  6. Monocyte chemoattractant protein 1

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

    Changes in monocyte chemoattractant protein 1

  7. Interleukin 6

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

    Changes in interleukin 6

  8. Tumor necrosis factor alpha

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

    Changes in tumor necrosis factor alpha

  9. Glucose

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

    Changes in glucose

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Egg Nutrition Center

Registry information

Official study title

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

Acronym: SCENE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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