Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
2019年5月4日 更新者：Richard Bruno、Ohio State University
Cardiovascular disease (CVD) is the leading cause of death in the United States.
Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD.
Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear.
The health benefits of dairy on heart health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction.
This provides rationale to further investigate dairy as a dietary strategy to reduce PPH and risk for CVD.
The objective of this study is to define the extent to which dairy milk, and its whey and casein protein fractions, protect against postprandial vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.
研究概览
地位
完全的
条件
详细说明
This study consists of four, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, 3. oral glucose challenge in combination with whey protein isolate, and 4. oral glucose challenge in combination with sodium caseinate.
For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals.
On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.
研究类型
介入性
注册 (实际的)
23
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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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University
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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
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- hemoglobin A1c 5.7-6.4%
- non-dietary supplement user
- no medications affecting vasodilation, inflammation, or energy metabolism
- no CVD
- nonsmokers
- individuals having blood pressure <140/90 mmHg and total cholesterol <240 mg/dL
Exclusion Criteria:
- unstable weight (±2 kg)
- vegetarian or dairy allergy
- alcohol intake >3 drinks/day or >10 drinks/week
- ≥7 hours/week of aerobic activity
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：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：葡萄糖
这个研究日将持续大约三个小时，男性将与另一组相隔四天，女性将相隔一个月。
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在基线测量之后，参与者将在五分钟内消耗 75 克葡萄糖溶液。
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实验性的：葡萄糖加脱脂牛奶
这个研究日将持续大约三个小时，男性将与另一组相隔四天，女性将相隔一个月。
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在基线测量之后，参与者将在五分钟内消耗溶解在两杯脱脂牛奶中的 75 克葡萄糖。
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实验性的：Glucose with Whey Protein Isolate
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
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Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.
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实验性的：Glucose with Sodium Caseinate
This study day will last approximately three hours and will be separated from the other arms by four days for men and one month for women.
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Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.
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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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Vascular Endothelial Function
大体时间：Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)
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Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline)
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Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nitrite/Nitrate (NOx)
大体时间：Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
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NOx AUC for 0-180 minutes
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Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)
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Plasma Glucose
大体时间：Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
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Plasma glucose concentration from 0-180 minutes
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Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)
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Malondialdehyde (MDA)
大体时间：Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
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Plasma MDA measured as MDA AUC from 0-180 minutes
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Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)
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Arginine (ARG)
大体时间：ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes
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ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Asymmetric Dimethylarginine/Arginine (ADMA/ARG)
大体时间：ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes
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ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Symmetric Dimethylarginine/Arginine (SDMA/ARG)
大体时间：SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes
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SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2)
大体时间：Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes
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Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Insulin
大体时间：Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes
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Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Cholecystokinin (CCK)
大体时间：CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes
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CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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8-isoprostaglandin-F2a
大体时间：8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes
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8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
|
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8-isoprostaglandin-F2a/Arachidonic Acid
大体时间：8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
|
Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes
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8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
|
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Arachidonic Acid
大体时间：Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
|
Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes
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Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)
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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：Richard S Bruno, PhD, RD、Ohio State University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
- DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.
- Ballard KD, Bruno RS. Protective role of dairy and its constituents on vascular function independent of blood pressure-lowering activities. Nutr Rev. 2015 Jan;73(1):36-50. doi: 10.1093/nutrit/nuu013.
- Ballard KD, Mah E, Guo Y, Pei R, Volek JS, Bruno RS. Low-fat milk ingestion prevents postprandial hyperglycemia-mediated impairments in vascular endothelial function in obese individuals with metabolic syndrome. J Nutr. 2013 Oct;143(10):1602-10. doi: 10.3945/jn.113.179465. Epub 2013 Aug 21.
- McDonald JD, Mah E, Chitchumroonchokchai C, Dey P, Labyk AN, Villamena FA, Volek JS, Bruno RS. Dairy milk proteins attenuate hyperglycemia-induced impairments in vascular endothelial function in adults with prediabetes by limiting increases in glycemia and oxidative stress that reduce nitric oxide bioavailability. J Nutr Biochem. 2019 Jan;63:165-176. doi: 10.1016/j.jnutbio.2018.09.018. Epub 2018 Sep 25.
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
2015年6月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2018年2月1日
研究注册日期
首次提交
2015年6月24日
首先提交符合 QC 标准的
2015年6月24日
首次发布 (估计)
2015年6月26日
研究记录更新
最后更新发布 (实际的)
2019年5月14日
上次提交的符合 QC 标准的更新
2019年5月4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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