Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.
研究概览
简要总结
Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roasting degrees. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.
The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.
详细描述
Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roast levels. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.
The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at different roast levels.
After medical examination and approval, subjects will be randomly assigned to one of the four coffee treatments. Each study period correspond to the ingestion of one the treatments and study periods are separated by a one week washout period. Blood will be taken as a time course for 24h while urine will be collected for 30h. Investigators are also blinded with respect to the dose and the treatment given to the subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 - 60 years, male and female
- •healthy as determined by the medical questionnaire and the medical visit
- •normal weight: BMI 19 - 25
- •Coffee drinkers with an average consumption of 2-5 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
- •food allergy
- •Have had a major gastrointestinal surgery
- •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 > 5 cigarettes a day
- •Have given blood within the last 3 weeks before the start of the study
- •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
Composite of pharmacokinetics: sum of AUC of chlorogenic and phenolic acids the of extreme treatments.
时间窗: 18 months
次要结局
- Composite of pharmacokinetics: AUC, Sum of AUC, Cmax, Tmax and T1/2 of plasma chlorogenic and phenolic acids from the other treatments.(18 months)