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临床试验/NCT01696773
NCT01696773进行中(未招募)不适用

Enhancing Bioavailability and Nutritional Quality of Processed Tomato Products

Ohio State University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
12
试验地点
2
主要终点
Pharmacokinetics of Carotenoid Absorption

研究概览

简要总结

Eating a diet rich in tomatoes has been associated with decreased risk for a variety of diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments called carotenoids), which has been associated with the decreased risk of disease in those consuming tomato products; however, tomatoes also contain flavonoids, which may also have health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in a different form that in red tomatoes and this contributes to their characteristic orange color. This "orange lycopene" is more similar to the most common form of lycopene found in the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by the body.

The objectives of this study are to determine if carotenoids and flavonoids from Tangerine tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances by the body).

详细描述

The primary goal of this research is to determine if a processed Tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. This primary objective will be accomplished by quantifying carotenoids from post-prandial triglyceride-rich lipoprotein (TRL) fractions of plasma and flavonoids from whole plasma and urine, after subjects consume a meal containing Tangerine or red tomato juice. A secondary goal is to examine if short-term delivery of bioactives from Tangerine and red tomatoes impact markers of inflammation in humans. This secondary objective will be accomplished by analyzing plasma for both interleukin-6 (IL-6), a marker for inflammation, and RNA to assess alterations in transcription of genes that regulate inflammation.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Total cholesterol ≤200 mg/dL
  • Triglycerides ≤ 200mg/dL
  • BMI 18.5 to 30.0kg/m2
  • Not anemic (hemoglobin at or above 10g/dL and hematocrit at or above 30%)
  • Age 18-70 years

排除标准

  • Lactating, pregnant, or plan to be pregnant during study
  • Tobacco (cigarettes and chewing tobacco)
  • Metabolic disease, such as diabetes mellitus or thyroid dysfunction
  • Malabsorption disorders (e.g. ileus, Crohn's, ulcerative colitis, pancreatic insufficiency)
  • History of cancer, esophageal, gastric, or intestinal ulcers
  • History of liver or kidney insufficiency or failure
  • Auto-immune disorders
  • Chronic inflammation (e.g. rheumatoid arthritis)
  • Allergies to tomatoes or tomato products
  • Obesity (BMI > 30kg/m2) or underweight (BMI <18.5kg/m2)
  • Hypercholesterolemia (Total cholesterol > 200 mg/dL)
  • Triglycerides > 200mg/dL
  • Subjects taking non-steroidal anti-inflammatory medications (e.g. Aspirin, Advil, Tylenol, Aleve) for 72 hours prior to each day-long visit.
  • Anemia (hemoglobin below 10g/dL or hematocrit below 30%)
  • Blood donation within the last 8 weeks

结局指标

主要结局

Pharmacokinetics of Carotenoid Absorption

时间窗: 11 post-prandial blood samples will be taken over 12 hours

The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.

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

Jessica Cooperstone

Assistant Professor

Ohio State University

研究点 (2)

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