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临床试验/NCT04882423
NCT04882423终止不适用

Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans

Masonic Cancer Center, University of Minnesota2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Hydroxylated PhlP profile with cruciferous vegetables

研究概览

简要总结

This is a randomized trial with crossover design, where each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. The participants will refrain from meat products for 24 hours prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat one of four meals:

  1. grilled hamburger with no vegetables
  2. grilled hamburger with steamed broccoli and Brussels sprouts
  3. grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
  4. grilled hamburger with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks.

详细描述

Colon cancer is the third most common cancer in the U.S. Convincing evidence suggests that high intake of red meat increases colon cancer risk, according to the 2007 AICR/WCRF Second Expert Report. The likely responsible mutagens are heterocyclic aromatic amines (HAA), which form naturally during the cooking of meat, poultry, and fish at high temperatures. Bioactivation of HAA to carcinogenic metabolites is primarily mediated by phase I biotransformation enzymes. Evidence suggests that the activity of many of these enzymes can be modulated by constituents in apiaceous vegetables (parsnips, celery, etc.) and cruciferous vegetables (broccoli, cabbage, etc.)

In this trial researchers are comparing the effects of eating cruciferous vegetables, apiaceous vegetables, or both groups combined on HAA metabolism after eating grilled hamburger together in a single meal. They aim to define optimal dietary patterns and food combinations that maximize the safe excretion of dietary carcinogens through this trial. This contribution is significant because the knowledge gained will be applicable to the prevention of colon cancer as well as additional cancers.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or older
  • Non-smoker

排除标准

  • No history of gastrointestinal, hepatic, or renal disorders
  • Not currently taking any prescription or over-the-counter medications
  • Not currently taking any herbal/vitamins supplements
  • Not pregnant or lactating
  • No allergies or intolerances to the foods that will be used in the study (parsnips, parsley, celery, broccoli, Brussels sprouts, and hamburger)

结局指标

主要结局

Hydroxylated PhlP profile with cruciferous vegetables

时间窗: 24 hours

Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

Hydroxylated PhlP profile with apiaceous vegetables

时间窗: 24 hours

Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables

时间窗: 24 hours

Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

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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