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临床试验/NCT01734070
NCT01734070已完成不适用

Role of Cherry Consumption in Reducing Risk Factors for Human Chronic Inflammatory Diseases

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in lipid peroxidation

研究概览

简要总结

The goal of this study is to examine if chronic cherry consumption will decrease lipid peroxidation and serum concentration of inflammatory markers in human subjects with elevated serum C reactive protein (CRP), and to examine the relationship between serum concentrations of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce serum concentration of inflammatory markers, including CRP, inflammatory cytokines and adhesion molecules.

详细描述

The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory. Subjects will be asked to record all foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption). The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64. All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour of draw and the plasma stored frozen in different aliquots, until analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Healthy men and women
  • 45-65 years of age
  • serum CRP concentrations between 3-25 mg/L
  • BMI < 35 kg/m2

排除标准

  • BMI > 35 kg/m2
  • current infection
  • taking anti-inflammatory medications

结局指标

主要结局

Change in lipid peroxidation

时间窗: baseline, day 36, and day 64

The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. Fasting blood samples will be drawn on study day 36. The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.

次要结局

  • Change in serum concentration of inflammatory markers(baseline, day 36 and day 64)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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