Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention
研究概览
简要总结
This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child
详细描述
This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded randomized control
入排标准
- 年龄范围
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eats <1.5 cup of fruit and <2.0 cup of vegetables per day
- •Boys or girls
- •All ethnicities
排除标准
- •Known allergy to blueberries
- •Chronic kidney disease
- •Hormonal disease
- •Autoimmune disease
- •Bleeding disorders
- •Chronic infections
- •Type 2 and Type 1 diabetes mellitus
- •Attention deficit hyperactivity disorder
- •Opposition defiant disorder
- •Autistic spectrum disorder
- •Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
- •If the participants/parents perceive barriers with adhering to low-polyphenol meals
- •Parent or child refusal to stop nutritional supplements
- •Parent or child refusal to have blood drawn
结局指标
主要结局
Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention
时间窗: Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported
Fasting Blood and urine were collected at visit two and three following an overnight fasting. At visit three, children consumed a single dose of the study product and plasma and urine were collected
次要结局
- Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells(up to 2 weeks)
- T-lymphocyte Responsiveness to Immune Stressors(up to 2 weeks)
- Endothelial Function by Brachial Artery Flow Mediated Dilation(up to 2 weeks)