Dose-response Effect of Alcohol Ingestion on Steroid Profile (PROFETHYL/2)

October 4, 2017 updated by: Rafael de la Torre, Parc de Salut Mar

Dose-response Effect of Alcohol Ingestion on Steroid Profile: Gender and Ethnic Aspects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Parc Salut Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.

Other Names:
  • Vodka Absolut®
Experimental: 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.
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.

Other Names:
  • Vodka Absolut®
Placebo Comparator: 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.
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.
Other Names:
  • Lemon flavored-water Fontvella®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline steroid profile
Time Frame: 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.
From one day before administration till 24 hours after administration
Change from baseline Ethyl glucuronide concentrations
Time Frame: 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.
From baseline till 24 hours after administration
Change from baseline Urine Ethyl sulfate concentrations
Time Frame: 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.
From baseline till 24 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline alcohol breath air concentrations
Time Frame: From baseline till 6 hours after administration
Alcohol concentration in breath air will be determined baseline (pre-administration) and up to 6 hours post-administration.
From baseline till 6 hours after administration
Urine Creatinine concentrations
Time Frame: From one day before administration till 24 hours after administration
Creatinine will be determined in each urine sample
From one day before administration till 24 hours after administration
Change from baseline subjective effects of ethanol
Time Frame: From baseline till 6 hours after administration
Participants will self-report their experience on a Visual Analogical Scale (VAS): before administration and till 6h post-administration
From baseline till 6 hours after administration
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: Through study completion, an average of 1 year
Collection of adverse effects spontaneously by the participants and/or observed by the investigators.
Through study completion, an average of 1 year
Change from baseline heart rate
Time Frame: From baseline to 6 hours after administration
Monitoring heart rate before administration and till 6h post-administration.
From baseline to 6 hours after administration
Change from baseline oral temperature
Time Frame: From baseline to 6 hours after administration
Monitoring oral temperature before administration and till 6h post-administration.
From baseline to 6 hours after administration
Change from baseline blood pressure
Time Frame: From baseline to 6 hours after administration
Monitoring blood pressure before administration and till 6h post-administration.
From baseline to 6 hours after administration
Urine pH
Time Frame: From one day before administration till 24 hours after administration
pH will be determined in each urine sample
From one day before administration till 24 hours after administration
Urine specific gravity
Time Frame: From one day before administration till 24 hours after administration
Specific gravity will be determined in each urine sample
From one day before administration till 24 hours after administration
Uridine diphosphoglucuronosyltransferase family 2 member B17 (UGT2B17) deletion genotype
Time Frame: Baseline
A blood sample for genotyping will be collected. The buffy coat will be stored a -20 degrees celsius (ºC). If deemed necessary for the interpretation of results, DNA will be extracted and evaluated following quantitative multiplex amplification polymerase chain reaction (PCR) for the evaluation of UGT2B17 deletion and copy number variation (CNVs)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

World Anti-Doping Agency

Investigators

  • Principal Investigator: Rafael de la Torre, PhD, IMIM-Hospital del Mar Medical Research Institute
  • Study Chair: José Antonio Pascual, PhD, IMIM-Hospital del Mar Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFETHYL/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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