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临床试验/NCT00966550
NCT00966550已完成不适用

Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women

Clinical Nutrition Research Center, Illinois Institute of Technology2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年8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
25
试验地点
2
主要终点
IL-6 Concentrations

研究概览

简要总结

The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.

详细描述

This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.

The initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.

If subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Male and female
  • Between ages of 18-65
  • BMI between 19 and 24 and hsCRP < 1mg/L
  • BMI between 25 and 35 and hsCRP > 2.5mg/L
  • No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease

排除标准

  • Pregnant and/or lactating
  • allergies or intolerances to foods consumed in the study
  • fasting blood glucose > 110mg/dL
  • taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints
  • unusual dietary habits
  • actively trying to lose or gain weight
  • addicted to drugs or alcohol
  • medically documented psychiatric or neurological disturbances
  • smoker (past smoker allowed if cessation > 2 years)

结局指标

主要结局

IL-6 Concentrations

时间窗: 6 hour postprandial study

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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