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临床试验/NCT02605850
NCT02605850已完成不适用

Effects of Phytonutrients on Vascular Health

University of California, Los Angeles0 个研究点目标入组 32 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Number of Participants With Abnormal PAT Values That Are Related to Treatment

研究概览

简要总结

This study will determine the effects of beneficial compounds of plant foods, such as pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water and then measuring blood vessel dilation (endothelial function) by blood flow We also will measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and insulin in blood. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial plant foods can have on cardiovascular function

详细描述

A. Specific Aims and Objectives

  1. Peripheral arterial reactivity by tonometry after a high fat meal with pomegranate consumption
  2. To measure nitric oxide and insulin response after a high fat meal and pomegranate consumption These studies will lead to a better understanding of the role of bioactive substances from plant foods such as the pomegranate may demonstrate the importance of plant-based nutrients on cardiovascular health.

B. Background Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties.

Pomegranate (Punica granatum L.) is grown commercially in the Near East, India, Spain, Israel and the United States (California) where it is of significant economic importance. Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed and recognized for their health benefits. Pomegranate (Punica granatum L.) fruit possesses strong antioxidant, anti-inflammatory and antiproliferative properties.

High-calorie meals rich in saturated fat can lead to transient exaggerated elevations in blood glucose, free fatty acids, and triglycerides. This condition, termed postprandial dysmetabolism, generates excess free radicals (or reactive oxygen species). The ensuing oxidative stress triggers a biochemical cascade throughout the circulation, inducing inflammation, and endothelial dysfunction. These postprandial changes, when repeated multiple times each day, can create a milieu conducive for the development of atherosclerotic risk factors and coronary heart disease (CHD).

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18 - 35 years old males (inclusive)
  • Non-smokers
  • Must weigh a minimum of 110 pounds
  • Willing to maintain normal activity and eating patterns for the duration of the study
  • Willing to maintain their normal diet for the duration of the study but avoid pomegranate products and ellagitannin rich foods.

排除标准

  • Any chronic medical conditions
  • Abnormal liver function (AST and ALT > 2 x upper limit)
  • Currently taking steroidal drugs
  • Cancer treated within the past two years
  • Participation in a therapeutic research study within 30 days of baseline
  • Use of antibiotics within one month
  • Regular use of probiotics
  • Allergy or sensitivity to pomegranate products
  • Follow a vegetarian diet
  • Known HIV positive

结局指标

主要结局

Number of Participants With Abnormal PAT Values That Are Related to Treatment

时间窗: Change from Baseline vascular function at 6 weeks

The major outcomes are PAT changes after a test meal with and without pomegranate.

次要结局

  • Number of Participants With Abnormal Laboratory Values That Are Related to Treatment(Change from Baseline laboratory values at 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoping Li

Professor of Medicine

University of California, Los Angeles

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