Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sub-study B : Basal dosing of urinary phenolic compounds and their metabolites concentrations
研究概览
简要总结
This study aims at studying in depth the absorption and metabolism of phenolic compounds of olive oil, wine and beer. This study is divided into 2 sub-studies in order to evaluate each one of the objectives.
详细描述
The study is divided in two sub-studies to explore each objective.
One the one hand, a group of people will drink olive oil, or wine, or both. This is done to see if combining these two drinks will improve the absorption and bioavailibility of phenolic compounds that they contain, promoting by synergy their antioxidant activity at a postprandial level. The main compounds studied are the Resveratrol (RSVT), the Hydroxytyrosol (HT), tyrosol (TIR) and their metabolits.
One the other hand, an group of people will drink 3 different beers ( with 3 different degrees of alcohol), or wine, in order to study the absorption of TIR in relation to the alcohol degree. It also aims at assessing if the gas contained in beer contributes to TIR absorption.
At different times after the administration of drinks, urine and blood samples will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The subjects, because of the wine taste that cannot be hidden, will know what they drink, except from the three beers (the three types will not be distinguishable).
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 18 to 45 years old.
- •Understand and accepting the procedures of the trial and sign an informed consent.
- •Have a history and physical exams that show that there is no organic issue, and an analysis and ECG in the normal limits.
- •Have an BMI between 18.5 and 30 kg/m
- •caucasian race
排除标准
- •Persons with chronical disease
- •Persons with BMI>30 or <18.5 kg/m
- •Persons with history of multiple allergies or obvious intestinal, hepatic, renal issues or other problems that could suppose a deterioration of absorption, distribution or metabolism of polyphenols.
- •Persons who take anti-oxidant products, including vitamins, herbal medication or dietetics complementation that could interfere in the study objectives.
- •Persons with restrictive diet (including vegetarian diet).
- •Persons with history of hypersensibility or intolerance to alcohol.
- •Persons with a daily consumption of alcohol >50g or who have consumed illegal drug in the month preceding the study.
- •Persons who have participated in an other clinical trial the month preceding the study.
- •Persons who have done a blood donation during the last 3 months before the beginning of the study (only appliable to the subjects of A sub-study).
- •Persons who have a positive serology for B or C hepatitis or HIV.
- •Pregnant or breastfeeding women, or any other situation prohibiting alcohol consumption.
- •Persons who have consummed NSAIDs (especially acetylsalicylic acid) or antioxidants or vitamin complementation, during the 2 weeks preceding the beginning of the study.
- •Illiterate persons
结局指标
主要结局
Sub-study B : Basal dosing of urinary phenolic compounds and their metabolites concentrations
时间窗: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations
时间窗: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours
Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations
时间窗: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
Sub-study A : Postprandial dosing of plasmatic phenolic compounds and their metabolites concentrations
时间窗: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
次要结局
- Sub-study A : Postprandial dosing of plasmatic total cholesterol(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study B : Postprandial cardiovascular activity : blood pressure(30 minutes, 1hour, 2 hours and 4 hours post administration)
- Sub-study B : Postprandial cardiovascular activity: heart rate.(30 minutes, 1hour, 2 hours and 4 hours post administration)
- Sub-study B : Postprandial Concentration of alcohol in the exhaled breath(30 minutes, 1hour, 2 hours and 4 hours post administration)
- Sub-study B : Basal isoxanthohumol urinary concentration(2 hours before administration to administration (-2 to 0 hours))
- Sub-study B : Postprandial isoxanthohumol urinary concentration(0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration)
- Sub-study A : Postprandial dosing of plasmatic triglyceride(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Postprandial dosing of plasmatic oxidated-LDL(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Basal cardiovascular activity : endothelial function.(15 minutes before administration)
- Sub-study B : Basal cardiovascular activity : blood pressure(15 minutes before administration)
- Sub-study A : Postprandial dosing of plasmatic glucose(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Postprandial dosing of plasmatic LDL(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Basal cardiovascular activity : blood pressure(15 minutes before administration)
- Sub-study A : Postprandial cardiovascular activity : blood pressure(1 hour and 2 hours post administration)
- Sub-study B : Concentration of alcohol in the exhaled breath(15 minutes before administration)
- Sub-study B : Basal urinary urinary pH.(2 hours before administration to administration (-2 to 0 hours))
- Sub-study A : Postprandial dosing of plasmatic insulin(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Postprandial dosing of plasmatic HDL concentrations.(baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration)
- Sub-study A : Basal cardiovascular activity: heart rate(15 minutes before administration)
- Sub-study A : Postprandial cardiovascular activity : heart rate(1 hour and 2 hours post administration)
- Sub-study A : Postprandial cardiovascular activity: endothelial function.(1 hour and 2 hours post administration)
- Sub-study B : Basal cardiovascular activity: heart rate.(15 minutes before administration)
- Sub-study B : Basal urinary creatinine concentration(2 hours before administration to administration (-2 to 0 hours))
- Sub-study B : Postprandial urinary creatinine concentration(0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration)
- Sub-study B : Postprandial urinary urinary pH.(0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration)
研究者
Rafael de la Torre
Director of the Neurosciences Department in IMIM
Parc de Salut Mar