Egg Consumption, Skeletal Health, and Cognition in Normal Weight and Obese Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Body Composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/
- •Must be willing to provide a blood sample
- •Not allergic to egg or egg products, milk or milk products, or gelatin
排除标准
- •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
结局指标
主要结局
Body Composition
时间窗: 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
时间窗: 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.
Bone Outcomes
时间窗: 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.
次要结局
- Insulin like growth factor 1(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Vascular endothelial growth factor(Serum samples will be collected at baseline, 4.5 months and 9 months)
- C-reactive protein(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Monocyte chemoattractant protein 1(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Interleukin 6(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Tumor necrosis factor alpha(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Insulin(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Serum Lipids(Serum samples will be collected at baseline, 4.5 months and 9 months)
- Glucose(Serum samples will be collected at baseline, 4.5 months and 9 months)
研究者
Dr. Richard D. Lewis
UGA Foundation Professor in Family and Consumer Sciences
University of Georgia