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临床试验/NCT01398150
NCT01398150已完成不适用

Cranberry Enhances Human Immune Function and Reduces Illness

University of Florida1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Physiological modifications to immune cell function

研究概览

简要总结

The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.

详细描述

The study will be conducted as a randomized, double blind, placebo-controlled parallel trial. Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the Placebo group and each will be instructed to consume the test beverages twice a day for 70 days. The beverage is not commercially prepared juice, but is a beverage prepared with an extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24 hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B and NK cell numbers and then cultured in autologous serum for 10 days to determine how well they proliferate. The supernatant of 24 hour cultures will be used for cytokine determination. If cells have been primed by the beverage made with cranberry compounds, the investigators expect the cells to proliferate to a greater extent and have modified cytokine production compared to placebo. If the beverage made with cranberry compounds enhances the proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the cranberry beverage. Incidence of illness is not expected to change, only the severity of the illness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Health male or non-pregnant female
  • •Between the ages of 21 and 50
  • •BMI between 18 and 35

排除标准

  • •High blood pressure define as 140/90
  • •Ongoing or chronic illness or infection
  • •On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
  • •Taking plant-based dietary supplements, antioxidant supplements, or probiotics
  • •Vegetarian or strict vegan
  • •Consume more than 1 cup of tea (iced or hot) per day
  • •Consumes more than 2 glasses of alcoholic beverages per day
  • •Consume more than 7 fruits and vegetables per day

研究组 & 干预措施

Sweetened Beverage

Placebo Comparator

looks like and is given in the same way as the experimental treatment but contains no active ingredient

干预措施: Beverage made to look like the cranberry beverage (Dietary Supplement)

Cranberry Beverage

Experimental

15 ounce bottle of cranberry beverage consumed daily for 70 days

干预措施: Beverage made from cranberry compounds (Dietary Supplement)

结局指标

主要结局

Physiological modifications to immune cell function

时间窗: 70 days

Proliferation of γδ-T cells when cultured ex vivo in autologous serum

次要结局

  • Cold and flu symptoms(70 days)
  • Anti-inflammatory outcome(70 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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