Coffee Antioxidant Efficacy in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- oxidative stress
研究概览
简要总结
Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo
详细描述
This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 - 70 years, male and female
- •BMI 19 - 29 kg/m2
- •Coffee drinkers with an average consumption of 1-3 cups per day
- •having given informed consent
排除标准
- •Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer- Have had a gastrointestinal surgery, except appendicectomy
- •Difficulty to swallow
- •Have a regular consumption of medication
- •Have taken antibiotic therapy within the last 6 months
- •Alcohol consumption > 2 units a day
- •Smokers (more than 5 cigarettes per day)
- •Have given blood within the last 3 weeks
- •Volunteers who cannot be expected to comply with treatment
- •Currently participating or having participated in another clinical trial during the last 3 weeks
结局指标
主要结局
oxidative stress
时间窗: Change in plasma and in urine beta isoprostane from baseline to the last day of a 10-day period of product intake
The level of oxidative stress will be assessed through measurements of urine and plasma beta isoprostane
次要结局
- bioavailability of coffee phenolics(Change of plasma chrorogenic and phenolic acids from baseline to the last day of a 10-day period of product intake)