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临床试验/NCT00983086
NCT00983086已完成1 期

Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones

University Hospital, Clermont-Ferrand0 个研究点目标入组 24 人开始时间: 2007年8月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
24
主要终点
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function

研究概览

简要总结

Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus fruits are rich in vitamin C but also in various plant micronutrients which are the most abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular diseases. However, profits in health associated with taking these polyphenols are unknown and so far no clinical studies have been conducted to determine the contribution of polyphenols of citrus in this protection.

The main objectives of this project are (1) to characterize the effects of single dose and made repeated consumption of orange juice on vascular protection and the immune response and (2) to assess the specific role of polyphenols present in citrus fruits in this protection. To do this the investigators will conduct a clinical study, randomized and crossover, among healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar to that given by orange juice.

详细描述

Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 50 to 65 inclusive
  • Body mass index of 25 to 30 kg / m² (inclusive

排除标准

  • Hypertriglyceridemia or known hypercholesterolemia, treated or not
  • Serology HIV and / or HCV positive

结局指标

主要结局

Determine the effects of repeated consumption of orange juice or purified flavanones in immune function

时间窗: after consumption of orange juice

次要结局

  • Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance(after consumption of orange juice)
  • Evaluate the effects of chronic consumption of orange juice or purified flavanones on gene expression by a global transcriptomic approach in mononuclear cells from peripheral blood(after consumption of orange juice)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

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