Clinical trial NCT02869763: Dose-response Effect of Alcohol Ingestion on Steroid Profile
Official title: Dose-response Effect of Alcohol Ingestion on Steroid Profile: Gender and Ethnic Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Healthy
Keywords: Ethanol
Steroid profile
Pharmacokinetics
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: World Anti-Doping Agency
First posted: 2016-08-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline steroid profile
timeFrame: From one day before administration till 24 hours after administration
measure: Change from baseline Ethyl glucuronide concentrations
timeFrame: From baseline till 24 hours after administration
measure: Change from baseline Urine Ethyl sulfate concentrations
timeFrame: From baseline till 24 hours after administration
Secondary outcomes:
measure: Change from baseline alcohol breath air concentrations
timeFrame: From baseline till 6 hours after administration
measure: Urine Creatinine concentrations
timeFrame: From one day before administration till 24 hours after administration
measure: Change from baseline subjective effects of ethanol
timeFrame: From baseline till 6 hours after administration
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Through study completion, an average of 1 year
measure: Change from baseline heart rate
timeFrame: From baseline to 6 hours after administration
measure: Change from baseline oral temperature
timeFrame: From baseline to 6 hours after administration
measure: Change from baseline blood pressure
timeFrame: From baseline to 6 hours after administration
measure: Urine pH
timeFrame: From one day before administration till 24 hours after administration
measure: Urine specific gravity
timeFrame: From one day before administration till 24 hours after administration
measure: Uridine diphosphoglucuronosyltransferase family 2 member B17 (UGT2B17) deletion genotype
timeFrame: Baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Salut Mar
Study officials:
affiliation: IMIM-Hospital del Mar Medical Research Institute
name: Rafael de la Torre, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMIM-Hospital del Mar Medical Research Institute
name: José Antonio Pascual, PhD
role: STUDY_CHAIR
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