The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Release of pro-and anti-inflammatory cytokines ex vivo
研究概览
简要总结
The purpose of this study is to determine the inhibiting effects of a single consumption of tomato ketchup on inflammation which will be induced ex-vivo in human blood.
详细描述
The consumption of tomatoes and tomato products has been associated with a lower risk of developing cardiovascular disease and some types of cancer. Tomatoes and tomato products provide a good source of antioxidants (lipophilic and hydrophilic). The major tomato antioxidants comprise lycopene, α-tocopherol and ascorbic acid. It has been reported that these antioxidants in isolated form exert directly or indirectly anti-inflammatory effects in vitro. Studies with tomatoes or tomato products revealed that the observed anti-inflammatory effects could not be caused by the presence of only one antioxidant. It was suggested that these effects were due to the combination of antioxidants.
In recent cell culture studies with human endothelial cells we have shown that tomato ketchup exerts significant anti-inflammatory effects, which could be related to the particular composition of antioxidants, i.e. lycopene, ascorbic acid and α-tocopherol. Since, however, the relevance of the observed anti-inflammatory effects for humans is entirely unknown, the present pilot study aims to assess the acute effects of a single tomato ketchup consumption on ex vivo elicited inflammation in a small group of healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI ≤ 30 kg/m2
- •Age >18 years
排除标准
- •Occurence of any adverse event, in particular those which require the use of medication that might interfere with the effects and/or the uptake of the investigational products
- •Intolerance of study products
- •Occurence of a serious adverse event
- •Use of supplements, functional foods and/or other products containing tomatoes, vitamins, antioxidants and polyphenolic compounds
- •Use of a medically prescribed diet or slimming diet
- •Vegetarian or vegan lifestyle
- •Excessive alcohol consumption (< 28 consumptions (approximately 250 g alcohol) per week)
- •Participation in a clinical trial within 4 weeks before the study
- •Non-compliance with the demands of the study
结局指标
主要结局
Release of pro-and anti-inflammatory cytokines ex vivo
时间窗: 2 months
6h after consumption of tomato ketchup blood will be collected and challenged ex vivo with bacterial endotoxin (LPS) in order to elicit the release of pro- (TNF-alpha, IL-8) and anti-inflammatory cytokines (IL-10)
次要结局
- Chemotaxis of monocytes ex vivo(2 months)
- Antioxidant plasma concentrations(2 months)
研究者
Antje Weseler
Principal Investigator
Maastricht University Medical Center