Dose-response Effect of Alcohol Ingestion on Steroid Profile: Gender and Ethnic Aspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline steroid profile
研究概览
简要总结
The aim of the clinical trial is to study the intra-individual variation of steroid profile parameters after experimental administration of different doses of ethanol in Caucasian women.
详细描述
The introduction of the so called 'endocrine module' of the athlete's biological passport needs to consider the numerous reports showing the effect of ethanol ingestion on the steroid profile. A steroid profile would only be useful for longitudinal monitoring and statistical evaluation if it has not been altered by any uncontrolled circumstance, very particularly alcohol consumption.
There is an urgent need to study the perpetuation that alcohol ingestion causes to the individual steroid profile and if possible establish cut-off values for markers of ethanol ingestion granting that the steroid profile determined has not been affected by such ingestion.
Subjects will be genotyped for genetic deletion polymorphism in the uridine diphosphoglucuronosyltransferase family 2 member B17 gene (UGT2B17) related to testosterone glucuronidation regulation.
The objective of the clinical trial is to study the intra-individual variation of steroid profile parameters as a result of the ingestion of different doses of ethanol in Caucasian women (complementing previous studies performed in men).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants will be healthy women aged 18 to 55 years. Women will enter in studies at the follicular phase of the menstrual cycle, in order to avoid the interference of estrogens.
- •Female subjects (if not postmenopausal) possessing regular menstrual cycle between 26 and 32 days and willing to use effective methods of contraception through the study (sexual abstinence, vasectomized partner, sterilization, intrauterine device, double-barrier method).
- •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 18.5 to 29.9 kg/m2, and the weight from 50 to 100 kg.
- •Understanding and accepting the study procedures and signing the informed consent.
- •Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each session and until the end of the study.
- •Subjects with social or recreational alcohol consumption, at least 3 standard drinks/week and subjects with experience in several drunkenness.
排除标准
- •Not meeting the inclusion criteria.
- •History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
- •Having suffered any organic disease or major surgery in the three months prior to the study start.
- •History of psychiatric disorders.
- •Women presenting amenorrhea or who suffer from moderate to intense premenstrual syndrome. Female subjects using hormonal contraceptive hormones.
- •Smokers of more than 20 cigarettes per day.
- •Taking more than 30 g of alcohol a day
- •Regular use of any drug in the month prior to the study sessions. 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.
- •Ingestion of vitamin supplements or antioxidants or nonsteroidal anti-inflammatory drugs in the two weeks preceding the study.
- •Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
- •Subjects with intolerance or adverse reactions to ethanol.
- •Subjects who have suffered a hospitalization caused by alcohol intoxication or who have received treatment for drunkenness
- •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.
- •Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- •Subjects with positive serology to Hepatitis B, C or HIV.
- •Subjects who follow a vegetarian diet.
研究组 & 干预措施
10 g ethanol
31 mL of Vodka Absolut® diluted in 369 mL of lemon flavored-water (LFW) Fontvella®.
A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.
干预措施: 10 g ethanol (Dietary Supplement)
20 g ethanol
63 mL of Vodka Absolut® diluted in 337 mL of lemon flavored-water (LFW) Fontvella®.
A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass.
干预措施: 20 g ethanol (Dietary Supplement)
Water
400 mL of lemon flavored-water Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. The administration will be controlled: participants will have 5 minutes to drink each glass.
干预措施: Water (Dietary Supplement)
结局指标
主要结局
Change from baseline steroid profile
时间窗: From one day before administration till 24 hours after administration
24 hours urine will be collected before each experimental session and also up to 24 hours after administration.
Change from baseline Ethyl glucuronide concentrations
时间窗: From baseline till 24 hours after administration
Ethyl glucuronide in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.
Change from baseline Urine Ethyl sulfate concentrations
时间窗: From baseline till 24 hours after administration
Ethyl sulfate in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.
次要结局
- Change from baseline alcohol breath air concentrations(From baseline till 6 hours after administration)
- Urine Creatinine concentrations(From one day before administration till 24 hours after administration)
- Change from baseline subjective effects of ethanol(From baseline till 6 hours after administration)
- Number of Participants with Serious and Non-Serious Adverse Events(Through study completion, an average of 1 year)
- Change from baseline heart rate(From baseline to 6 hours after administration)
- Change from baseline oral temperature(From baseline to 6 hours after administration)
- Change from baseline blood pressure(From baseline to 6 hours after administration)
- Urine pH(From one day before administration till 24 hours after administration)
- Urine specific gravity(From one day before administration till 24 hours after administration)
- Uridine diphosphoglucuronosyltransferase family 2 member B17 (UGT2B17) deletion genotype(Baseline)
研究者
Rafael de la Torre
PhD Pharm D
Parc de Salut Mar