Bone HealthSCENENCT03739424
Skeletal and Cognitive Effects of Nutrition From Eggs
A study testing Whole egg powder, Whole milk powder and Gelatin food product in people with Bone Health and Cognitive Health, run by University of Georgia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Cognitive Health
- What is being tested?
- Whole egg powder, Whole milk powder and Gelatin food product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2018to 11 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Health, Cognitive Health
- Being tested
- Whole egg powder, Whole milk powder, Gelatin food product
- Keywords
- Bone, Cognition, Egg, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole egg powderOther
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 powderOther
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 productOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Gelatin food product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Changes in cognitive function will be assessed from baseline to 4.5 and 9 months
Secondary outcomes (9)
Serum Lipids
Changes in serum lipids
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Insulin
Changes in serum insulin
Measured: 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
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Vascular endothelial growth factor
Changes in vascular endothelial growth factor
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
C-reactive protein
Changes in C-reactive protein
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Monocyte chemoattractant protein 1
Changes in monocyte chemoattractant protein 1
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Interleukin 6
Changes in interleukin 6
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Tumor necrosis factor alpha
Changes in tumor necrosis factor alpha
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Glucose
Changes in glucose
Measured: Serum samples will be collected at baseline, 4.5 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start28 Apr 2018
- Primary completion11 Jul 2020
- Study completion11 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Principal investigator, Dr. Richard D. Lewis, University of Georgia
- Investigators
- Richard D Lewis, PhD, Principal investigator, University of GeorgiaNicole J Crenshaw, Study director, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739424
- Sponsor's protocol ID
- 2521RC296228
- Acronym
- SCENE
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23952203Akshoomoff 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.
PubMed 24219608Weintraub 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.
PubMed 23479546Zelazo 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.
PubMed 23952200O'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.
PubMed 36173384
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Consumption, Skeletal Health, and Cognition in Normal Weight and Obese Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03739424
- Acronym / sponsor ID
- SCENE / 2521RC296228
- Conditions
- Bone Health, Cognitive Health
- Keywords
- Bone, Cognition, Egg, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 11 Jul 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole egg powder arm | Experimental | Other: Whole egg powderThe 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 milk powder arm | Active comparator | Other: Whole milk powderThe 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. |
| Gelatin arm | Placebo comparator | Other: Gelatin food productThe 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole egg powderParticipants 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. | Other | Whole egg powder arm |
| Whole milk powderParticipants 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. | Other | Whole milk powder arm |
| Gelatin food productParticipants 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. | Other | Gelatin arm |
Primary outcome
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.
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.
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.
9 secondary outcomes
Serum Lipids
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Insulin
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Insulin like growth factor 1
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Vascular endothelial growth factor
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
C-reactive protein
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Monocyte chemoattractant protein 1
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Interleukin 6
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Tumor necrosis factor alpha
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Glucose
Time frame: Serum samples will be collected at baseline, 4.5 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Results publication: PubMed 23952203Tulsky 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.
- Results publication: PubMed 24219608Akshoomoff 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.
- Results publication: PubMed 23479546Weintraub 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.
- Results publication: PubMed 23952200Zelazo 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.
- Derived from this study: PubMed 36173384O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Lewis, PhD principal investigator
University of Georgia
Nicole J Crenshaw study director
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole egg powder, Whole milk powder and Gelatin food product in people with Bone Health and Cognitive Health, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Outcomes (time frame: Assess changes in bone outcomes from baseline to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03739424, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.