Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in Microvascular Function
研究概览
简要总结
The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).
详细描述
Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection.
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
- Double (Participant, Investigator)
盲法说明
Products will look and taste similar, and will be provided in coded packaging
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
- •Male or Female 9-13 years old
- •Subject is willing and able to comply with the study protocols
- •Subject is willing to consume the test products
- •Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study
排除标准
- •Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- •Under current medical supervision
- •Tanner Score = 4
- •Non-English speaking
- •Current participation in a daily exercise routine of moderate or high intensity
- •Self-reported presence of disease, a history of serious illness, or who are currently under acute medical care.
- •Currently taking prescription drugs or supplements
- •Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
- •Self-reported malabsorption or gastrointestinal issues
- •Current enrollee in a clinical research study.
结局指标
主要结局
Change in Microvascular Function
时间窗: Compare change in baseline and 4 weeks
Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
次要结局
- Change in Lipidome(Compare change in baseline and 4 weeks)
- Change in Inflammatory Markers(Compare change in baseline and 4 weeks)
- Change in Metabolome(Compare change in baseline and 4 weeks)