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临床试验/NCT01568827
NCT01568827已完成1 期

Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal

Ohio State University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Serum IL-6

研究概览

简要总结

Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.

详细描述

A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • adult males over 55 years of age
  • overweight or obese

排除标准

  • history of adverse reaction to berries or berry products
  • history of adverse reaction to high-fat, high-calorie challenge meal
  • significant liver or renal insufficiency
  • significant cognitive impairment

结局指标

主要结局

Serum IL-6

时间窗: acute (0-12 hours) after inflammation-causing challenge meal

Area Under the time-concentration Curve (AUC) of IL-6

次要结局

未报告次要终点

研究者

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

Joseph Kitzmiller

Assistant Professor

Ohio State University

研究点 (2)

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