Assessment of a New Food Product in Metabolically at Risk Children
2019年5月28日 更新者：University of California, Davis
Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
68
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Davis、California、美国、95616
- Department of Nutrition
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
9年 至 13年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Food Product 1
Macronutrient similar to experimental, micronutrient lower than experimental
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Each food product will provide similar calories, but a different micro- and macro-nutrient composition
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有源比较器：Food Product 2
Macronutrient lower than experimental, micronutrient similar to experimental
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Each food product will provide similar calories, but a different micro- and macro-nutrient composition
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实验性的：Food Product 3
Experimental 1
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Each food product will provide similar calories, but a different micro- and macro-nutrient composition
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实验性的：Food Product 4
Experimental 2
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Each food product will provide similar calories, but a different micro- and macro-nutrient composition
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Microvascular Function
大体时间：Compare change in baseline and 4 weeks
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Measured by EndoPAT2000.
A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
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Compare change in baseline and 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Metabolome
大体时间：Compare change in baseline and 4 weeks
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Measured with Nuclear Magnetic Resonance (NMR)
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Compare change in baseline and 4 weeks
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Change in Lipidome
大体时间：Compare change in baseline and 4 weeks
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Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
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Compare change in baseline and 4 weeks
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Change in Inflammatory Markers
大体时间：Compare change in baseline and 4 weeks
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Measured by immunoassay
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Compare change in baseline and 4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Carl L Keen, PhD、Principal Investigator
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月15日
初级完成 (实际的)
2018年3月24日
研究完成 (实际的)
2018年5月24日
研究注册日期
首次提交
2017年2月13日
首先提交符合 QC 标准的
2017年5月31日
首次发布 (实际的)
2017年6月5日
研究记录更新
最后更新发布 (实际的)
2019年5月30日
上次提交的符合 QC 标准的更新
2019年5月28日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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