Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
Hydroxytyrosol as an Endogenous and Natural Antioxidant: Modulation by Alcohol Intake. Substudy 2. To Establish the Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Barcelona、西班牙、08003
- Parc de Salut Mar
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Understanding and accepting the study procedures and signing the informed consent.
- Male and female volunteers aged 18 to 55 years. No fixed sex ratio has been established.
- Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- The body mass index (BMI=weigh/height2) will range from 19 to 25 kg/m2, and the weight from 50 to 100 kg. 25-27 could be accepted.
- Women with regular menstrual cycle of 26-32 days.
- Subjects socially drinking and who had ingested wine at least once.
Exclusion Criteria:
- Not meeting the inclusion criteria.
- History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
- Blood donation in the previous 8 weeks or participation in other clinical trials with drugs in the previous 12 weeks.
- Having suffered any organic disease or major surgery in the three months prior to the study start.
- Subjects with intolerance or serious adverse reactions to ethanol.
- Regular use of any drug in the month prior to the study sessions, except for vitamins or diet supplements, that, in the opinion of the principal investigator or co-investigators designated by him, do not involve a risk for the subject and do not interfere with the study objectives. In this case they should be discontinued from one week before the experimental sessions to the end of them. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- Taking more than 20 g of alcohol a day in women and more than 30 g in men.
- Taking more than 5 coffees, teas, cola drinks or other stimulating drinks or with xanthines daily in the 3 months prior to the study start.
- Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- Smokers or ex-smokers of less than one year.
- Subjects with positive serology to Hepatitis B, C or HIV.
- Pregnant or nursing women or positive pregnancy test in urine. Women not undertaking to follow reliable contraceptive measures during the study (such as abstinence, hormonal contraceptives, intrauterine devices, double-barrier methods or vasectomised partner).
- Women with amenorrhea or premenstrual syndrome of moderate or severe intensity.
- Nonsteroidal anti-inflammatory drugs, antioxidants or vitamins consumption in the last 2 weeks.
- Total cholesterol >6.00 mmol/l (240 mg/dl) or triglycerides >2.26 mmol/l (200 mg/dl).
- Vegetarians or subjects following aberrant diets.
- Physical exercise of >2h/day or >3000 kcal /week.
To be eligible, the subjects must agree to follow a poor polyphenols diet in the 72 hours prior to the start of each session and until 24 hours after.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:Water
Lemon-flavored water.
293 ml in pilot A, 147 ml in pilot B, 235 ml in pilot C, 147 ml in the definitive study.
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Lemon-flavored water
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有源比较器:Alcoholized wine
Wine 13º in pilot A (293 ml), B (147 ml) and the definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and 15 g of ethanol in the definitive study. Wine 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. |
Wine 13º or wine 8º
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安慰剂比较:De-alcoholized wine
Wine 0º.
Pilot A: 293ml; pilot B: 147 ml; pilot C: 235 ml; definitive study: 147 ml.
Corresponding to 0 g of ethanol.
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Wine 0º
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有源比较器:Ethanol
Ethanol 13º in pilot A (293 ml), B (147 ml) and definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and in the definitive study. Ethanol 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. Ethanol was administered as a single dose of Vodka Absolut (40º) diluted in lemon-flavored water. |
Vodka Absolut
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
羟基酪醇生物体液浓度
大体时间:给药后0-24小时
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血浆和尿液中的羟基酪醇浓度
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给药后0-24小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
主观醉酒
大体时间:给药后0-6h
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使用视觉模拟量表测量乙醇的主观影响
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给药后0-6h
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乙醇浓度
大体时间:给药后0-6h
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乙醇血液浓度
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给药后0-6h
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乙醇代谢物浓度
大体时间:给药后0-24小时
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尿液中乙醇代谢物的回收
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给药后0-24小时
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多巴胺代谢物浓度
大体时间:给药后0-24小时
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尿液中多巴胺代谢物的回收
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给药后0-24小时
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Vital signs
大体时间:0-24h after administration
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Blood pressure, oral temperature and heart rate
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0-24h after administration
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Oxidation biomarkers of proteins and lipids
大体时间:0-24h after administration
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0-24h after administration
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Psychomotor performance (DSST)
大体时间:0-6h after administration
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Psychomotor performance assessed by means of Digit symbol substitution test (DSST)
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0-6h after administration
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Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence
大体时间:Baseline
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Baseline
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Platelets monoamine oxidase-B activity
大体时间:Baseline
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Baseline
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Breath ethanol
大体时间:30 min after administration
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Breath ethanol concentration
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30 min after administration
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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