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临床试验/NCT02210234
NCT02210234已完成不适用

Wheat Bioactives and Immune Function

University of Florida2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年5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
43
试验地点
2
主要终点
γδ-T cell proliferation

研究概览

简要总结

The purpose of this research was to understand the effects of bioactive compounds found in wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function assays were performed at both sampling times. It was predicted that eating wheat bran would benefit immune function.

详细描述

Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of mouth on the University of Florida campus and in the surrounding area, in May of 2010. Eligible subjects were randomly assigned to one of two experimental groups, to consume either 50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from fasting subjects before consumption (baseline) and after three weeks of cereal consumption. Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow cytometry and analyzed. Overall compliance was assessed using self-reported data and by counting left-over bags of cereal.

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
None

入排标准

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

入选标准

  • generally healthy
  • aged 18-65

排除标准

  • chronic health problems
  • high blood pressure
  • BMI greater than 25

结局指标

主要结局

γδ-T cell proliferation

时间窗: Change in Baseline and 3 weeks

Flow cytometry is used to compare the percentage of γδ-T cells in the total CD3 cell population in the blood of subjects before and after three weeks of consuming whole wheat bran cereal. An increase in that percentage would be suggestive of improved immunity (priming).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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