Bone Health Clinical Trial
— SCENEOfficial title:
Egg Consumption, Skeletal Health, and Cognition in Normal Weight and Obese Children: A Randomized Controlled Trial
Verified date | November 2020 |
Source | University of Georgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 182 |
Est. completion date | July 11, 2020 |
Est. primary completion date | July 11, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 13 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Georgia | Athens | Georgia |
Lead Sponsor | Collaborator |
---|---|
University of Georgia | Egg Nutrition Center |
United States,
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 Cognitio — View 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. — View 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 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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. | |
Primary | 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 | Serum Lipids | Changes in serum lipids | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Insulin | Changes in serum insulin | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Insulin like growth factor 1 | Changes in insulin like growth factor 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Vascular endothelial growth factor | Changes in vascular endothelial growth factor | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | C-reactive protein | Changes in C-reactive protein | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Monocyte chemoattractant protein 1 | Changes in monocyte chemoattractant protein 1 | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Interleukin 6 | Changes in interleukin 6 | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Tumor necrosis factor alpha | Changes in tumor necrosis factor alpha | Serum samples will be collected at baseline, 4.5 months and 9 months | |
Secondary | Glucose | Changes in glucose | Serum samples will be collected at baseline, 4.5 months and 9 months |
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