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Dried Cabernet Grapes and Cardiovascular Risk Markers (RZN)

2017年10月3日 更新者:University of California, Davis

Effects of CabernayZyns (Dried Cabernet Grapes) Intake on Vascular Function and Platelet Reactivity in Postmenopausal Women

This study assesses the acute effects of dried Cabernet grape intake on vascular function and platelet reactivity in postmenopausal women. Previous studies from this lab and others have demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich food sources. Postmenopausal women are suggested as the study group, as they are likely to have compromised vascular function due to the loss of protective estrogen, and have been the study group for past and present research projects in this lab.

研究概览

详细说明

The initiation and progression of atherosclerotic cardiovascular disease (CVD) is multifactorial in nature, and is currently thought of as a chronic inflammatory condition. To reduce the risk of CVD and its associated health care costs in California and elsewhere, nutrition and health recommendations strongly advocate the consumption of a diet rich in fruits and vegetables. Such recommendations are based largely on epidemiological data; the mechanisms underlying the putative positive effects of plant food-rich diets are poorly defined and an area of active debate.

In addition to essential vitamins and minerals, fruits and vegetables contain a number of bioactive compounds that may be involved in vascular function. In this regard, epidemiological studies have noted a significant inverse relationship between the intake of plant foods rich in polyphenols and the risk of both all-cause mortality and CVD. For example, the "French paradox" refers to diet patterns that, despite being high in saturated fat, are associated with a relatively low cardiovascular risk, which may be due, in part, to a robust intake of polyphenols found in red wine, grapes, and other plant foods. Red wine contains an array of phytochemicals that have been proposed to improve cardiovascular health, with a great focus on polyphenols. However, grape products such as dried cabernet grapes also contain substantial amounts of polyphenols that may be vasculoprotective.

研究类型

介入性

注册 (实际的)

20

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

    • California
      • Davis、California、美国、95616
        • Ragle Human Nutrition Center

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

50年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Postmenopausal female: 50-70 years
  • Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL
  • Subject is willing and able to comply with the study protocols.
  • Subject is willing to participate in all study procedures
  • BMI 25.0 - 40 kg/m2
  • Weight ≥ 110 pounds

Exclusion Criteria:

  • BMI ≥ 40 kg/m2
  • Dislike or allergy for grape products and raisins
  • Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
  • Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
  • Alcohol consumption > 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
  • Fruit consumption ≥ 2 cups/day
  • Vegetable consumption ≥ 3 cups/day for females
  • Fatty Fish ≥ 3 times/week
  • Coffee/tea ≥ 3 cups/day
  • Dark chocolate ≥ 3 oz/day
  • Self-reported restriction of physical activity due to a chronic health condition
  • Self-reported chronic/routine high intensity exercise
  • Self-reported diabetes
  • Blood pressure ≥ 140/90 mm Hg
  • Self-reported renal or liver disease
  • Self-reported heart disease, which includes cardiovascular events and stroke
  • Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
  • Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
  • Self-reported cancer within past 5 years
  • Self-reported malabsorption
  • Currently taking prescription drugs or supplements.
  • Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA
  • Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
  • Indications of substance or alcohol abuse within the last 3 years
  • Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].
  • Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL].

(using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);

  • Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
  • Current enrollee in a clinical research study.

The following special populations will be excluded:

  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

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
实验性的:Raisin Treatment
3.2 ounces of dried Cabernet wine grapes.
Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.
Subjects will consume 95g of whole wheat bagel during a single intervention time point.
其他:Bagel Control
One 95g whole wheat bagel.
Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.
Subjects will consume 95g of whole wheat bagel during a single intervention time point.

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
Change in Postprandial Micro-vascular Function
大体时间:Baseline and 2-hour measures on day 0 and day 7.
To determine whether an acute intake of dried Cabernet grapes will improve vascular function, as measured using peripheral artery tonometry (PAT).
Baseline and 2-hour measures on day 0 and day 7.

次要结果测量

结果测量
措施说明
大体时间
Platelet Aggregation
大体时间:Baseline and 2-hour measures on day 0 and day 7.
To determine whether an acute intake of dried Cabernet grapes will alter platelet reactivity, as measured by Chrono-log platelet aggregometer device.
Baseline and 2-hour measures on day 0 and day 7.
Nitrate/Nitrite
大体时间:Baseline and 2-hour measures on day 0 and day 7.
Blood analysis to determine whether an acute intake of dried Cabernet grapes will affect plasma circulating nitrate and nitrite levels.
Baseline and 2-hour measures on day 0 and day 7.
Baseline Complete Metabolic Panel
大体时间:Baseline measures on day 0 and day 7.
Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.
Baseline measures on day 0 and day 7.
Postprandial Complete Metabolic Panel
大体时间:2-hour measures on day 0 and day 7.
Blood analyses will include measurements of complete blood cell count, comprehensive metabolic panel, and lipid profile.
2-hour measures on day 0 and day 7.
Body Weight
大体时间:Baseline measure on day 0 and day 7.
Body weight will be recorded at baseline on initial visit as well as visit one week after.
Baseline measure on day 0 and day 7.
Blood Pressure
大体时间:Baseline measure on day 0 and day 7.
The office blood pressure measurement will be obtained (3 measurements 5 minutes apart after a 15 minute rest).
Baseline measure on day 0 and day 7.

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。

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

2016年9月1日

初级完成 (实际的)

2017年4月1日

研究完成 (实际的)

2017年7月1日

研究注册日期

首次提交

2017年2月14日

首先提交符合 QC 标准的

2017年2月21日

首次发布 (实际的)

2017年2月27日

研究记录更新

最后更新发布 (实际的)

2017年10月4日

上次提交的符合 QC 标准的更新

2017年10月3日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 944091

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

Raisin Treatment的临床试验

3
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