Alcohol ConsumptionPROFETHYL/2NCT02869763
Dose-response Effect of Alcohol Ingestion on Steroid Profile
A study testing 10 g ethanol, 20 g ethanol and Water in people with Alcohol Consumption and Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Healthy
- What is being tested?
- 10 g ethanol, 20 g ethanol and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Alcohol Consumption, Healthy
- Being tested
- 10 g ethanol, 20 g ethanol, Water
- Keywords
- Ethanol, Steroid profile, Pharmacokinetics
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 g ethanolDietary supplement
Also called Vodka Absolut®
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.
20 g ethanolDietary supplement
Also called Vodka Absolut®
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.
WaterDietary supplement
Also called Lemon flavored-water Fontvella®
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 g ethanol | Experimental | 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. Receives: Dietary Supplement: 10 g ethanol |
| 20 g ethanol | Experimental | 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. Receives: Dietary Supplement: 20 g ethanol |
| Water | Placebo comparator | 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. Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline steroid profile
24 hours urine will be collected before each experimental session and also up to 24 hours after administration.
Measured: From one day before administration till 24 hours after administration
Change from baseline Ethyl glucuronide concentrations
Ethyl glucuronide in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.
Measured: From baseline till 24 hours after administration
Change from baseline Urine Ethyl sulfate concentrations
Ethyl sulfate in urine will be measured by Liquid chromatography-mass spectrometry (LC-MS) using deuterated analogs as Internal Standards.
Measured: From baseline till 24 hours after administration
Secondary outcomes (10)
Change from baseline alcohol breath air concentrations
Alcohol concentration in breath air will be determined baseline (pre-administration) and up to 6 hours post-administration.
Measured: From baseline till 6 hours after administration
Urine Creatinine concentrations
Creatinine will be determined in each urine sample
Measured: From one day before administration till 24 hours after administration
Change from baseline subjective effects of ethanol
Participants will self-report their experience on a Visual Analogical Scale (VAS): before administration and till 6h post-administration
Measured: From baseline till 6 hours after administration
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously by the participants and/or observed by the investigators.
Measured: Through study completion, an average of 1 year
Change from baseline heart rate
Monitoring heart rate before administration and till 6h post-administration.
Measured: From baseline to 6 hours after administration
Change from baseline oral temperature
Monitoring oral temperature before administration and till 6h post-administration.
Measured: From baseline to 6 hours after administration
Change from baseline blood pressure
Monitoring blood pressure before administration and till 6h post-administration.
Measured: From baseline to 6 hours after administration
Urine pH
pH will be determined in each urine sample
Measured: From one day before administration till 24 hours after administration
Urine specific gravity
Specific gravity will be determined in each urine sample
Measured: From one day before administration till 24 hours after administration
Uridine diphosphoglucuronosyltransferase family 2 member B17 (UGT2B17) deletion genotype
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- World Anti-Doping Agency
- Responsible party
- Principal investigator, Rafael de la Torre, Parc de Salut Mar
- Investigators
- Rafael de la Torre, PhD, Principal investigator, IMIM-Hospital del Mar Medical Research InstituteJosé Antonio Pascual, PhD, Study chair, IMIM-Hospital del Mar Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869763
- Sponsor's protocol ID
- PROFETHYL/2
- Acronym
- PROFETHYL/2
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arranz S, Chiva-Blanch G, Valderas-Martinez P, Medina-Remon A, Lamuela-Raventos RM, Estruch R. Wine, beer, alcohol and polyphenols on cardiovascular disease and cancer. Nutrients. 2012 Jul;4(7):759-781. doi: 10.3390/nu4070759. Epub 2012 Jul 10.
PubMed 22852062Bagnardi V, Zatonski W, Scotti L, La Vecchia C, Corrao G. Does drinking pattern modify the effect of alcohol on the risk of coronary heart disease? Evidence from a meta-analysis. J Epidemiol Community Health. 2008 Jul;62(7):615-9. doi: 10.1136/jech.2007.065607.
PubMed 18559444Dahl H, Hammarberg A, Franck J, Helander A. Urinary ethyl glucuronide and ethyl sulfate testing for recent drinking in alcohol-dependent outpatients treated with acamprosate or placebo. Alcohol Alcohol. 2011 Sep-Oct;46(5):553-7. doi: 10.1093/alcalc/agr055. Epub 2011 May 26.
PubMed 21616946Dahl H, Stephanson N, Beck O, Helander A. Comparison of urinary excretion characteristics of ethanol and ethyl glucuronide. J Anal Toxicol. 2002 May-Jun;26(4):201-4. doi: 10.1093/jat/26.4.201.
PubMed 12054359Jatlow PI, Agro A, Wu R, Nadim H, Toll BA, Ralevski E, Nogueira C, Shi J, Dziura JD, Petrakis IL, O'Malley SS. Ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcohol Clin Exp Res. 2014 Jul;38(7):2056-65. doi: 10.1111/acer.12407. Epub 2014 Apr 28.
PubMed 24773137Di Castelnuovo A, Costanzo S, Bagnardi V, Donati MB, Iacoviello L, de Gaetano G. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006 Dec 11-25;166(22):2437-45. doi: 10.1001/archinte.166.22.2437.
PubMed 17159008Falk O, Palonek E, Bjorkhem I. Effect of ethanol on the ratio between testosterone and epitestosterone in urine. Clin Chem. 1988 Jul;34(7):1462-4.
PubMed 3390919Gaedigk A, Twist GP, Leeder JS. CYP2D6, SULT1A1 and UGT2B17 copy number variation: quantitative detection by multiplex PCR. Pharmacogenomics. 2012 Jan;13(1):91-111. doi: 10.2217/pgs.11.135. Epub 2011 Nov 23.
PubMed 22111604Grosse J, Anielski P, Sachs H, Thieme D. Ethylglucuronide as a potential marker for alcohol-induced elevation of urinary testosterone/epitestosterone ratios. Drug Test Anal. 2009 Nov;1(11-12):526-30. doi: 10.1002/dta.110.
PubMed 20355168Halter CC, Dresen S, Auwaerter V, Wurst FM, Weinmann W. Kinetics in serum and urinary excretion of ethyl sulfate and ethyl glucuronide after medium dose ethanol intake. Int J Legal Med. 2008 Mar;122(2):123-8. doi: 10.1007/s00414-007-0180-8. Epub 2007 Jun 9.
PubMed 17558515Jakobsson J, Ekstrom L, Inotsume N, Garle M, Lorentzon M, Ohlsson C, Roh HK, Carlstrom K, Rane A. Large differences in testosterone excretion in Korean and Swedish men are strongly associated with a UDP-glucuronosyl transferase 2B17 polymorphism. J Clin Endocrinol Metab. 2006 Feb;91(2):687-93. doi: 10.1210/jc.2005-1643. Epub 2005 Dec 6.
PubMed 16332934American Heart Association Nutrition Committee; Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19.
PubMed 16785338Rinaldi S, Peeters PH, Bezemer ID, Dossus L, Biessy C, Sacerdote C, Berrino F, Panico S, Palli D, Tumino R, Khaw KT, Bingham S, Allen NE, Key T, Jensen MK, Overvad K, Olsen A, Tjonneland A, Amiano P, Ardanaz E, Agudo A, Martinez-Garcia C, Quiros JR, Tormo MJ, Nagel G, Linseisen J, Boeing H, Schulz M, Grobbee DE, Bueno-de-Mesquita HB, Koliva M, Kyriazi G, Thrichopoulou A, Boutron-Ruault MC, Clavel-Chapelon F, Ferrari P, Slimani N, Saracci R, Riboli E, Kaaks R. Relationship of alcohol intake and sex steroid concentrations in blood in pre- and post-menopausal women: the European Prospective Investigation into Cancer and Nutrition. Cancer Causes Control. 2006 Oct;17(8):1033-43. doi: 10.1007/s10552-006-0041-7.
PubMed 16933054Santner SJ, Albertson B, Zhang GY, Zhang GH, Santulli M, Wang C, Demers LM, Shackleton C, Santen RJ. Comparative rates of androgen production and metabolism in Caucasian and Chinese subjects. J Clin Endocrinol Metab. 1998 Jun;83(6):2104-9. doi: 10.1210/jcem.83.6.4898.
PubMed 9626146Snell LD, Ramchandani VA, Saba L, Herion D, Heilig M, George DT, Pridzun L, Helander A, Schwandt ML, Phillips MJ, Hoffman PL, Tabakoff B; WHO/ISBRA Study on State and Trait Markers of Alcohol Use and Dependence Investigators. The biometric measurement of alcohol consumption. Alcohol Clin Exp Res. 2012 Feb;36(2):332-41. doi: 10.1111/j.1530-0277.2011.01605.x. Epub 2011 Sep 6.
PubMed 21895709
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effect of Alcohol Ingestion on Steroid Profile: Gender and Ethnic Aspects
- ClinicalTrials.gov ID
- NCT02869763
- Acronym / sponsor ID
- PROFETHYL/2 / PROFETHYL/2
- Conditions
- Alcohol Consumption, Healthy
- Keywords
- Ethanol, Steroid profile, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- World Anti-Doping Agency
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 g ethanol | Experimental | Dietary Supplement: 10 g ethanol31 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. |
| 20 g ethanol | Experimental | Dietary Supplement: 20 g ethanol63 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. |
| Water | Placebo comparator | Dietary Supplement: Water400 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 g ethanolAlso: Vodka Absolut®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 |
| 20 g ethanolAlso: Vodka Absolut®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 |
| WaterAlso: Lemon flavored-water Fontvella®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 |
Primary outcome
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.
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.
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.
10 secondary outcomes
Change from baseline alcohol breath air concentrations
Time frame: From baseline till 6 hours after administration
Urine Creatinine concentrations
Time frame: 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
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Through study completion, an average of 1 year
Change from baseline heart rate
Time frame: From baseline to 6 hours after administration
Change from baseline oral temperature
Time frame: From baseline to 6 hours after administration
Change from baseline blood pressure
Time frame: From baseline to 6 hours after administration
Urine pH
Time frame: 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
Uridine diphosphoglucuronosyltransferase family 2 member B17 (UGT2B17) deletion genotype
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Results publication: PubMed 22852062Arranz S, Chiva-Blanch G, Valderas-Martinez P, Medina-Remon A, Lamuela-Raventos RM, Estruch R. Wine, beer, alcohol and polyphenols on cardiovascular disease and cancer. Nutrients. 2012 Jul;4(7):759-781. doi: 10.3390/nu4070759. Epub 2012 Jul 10.
- Results publication: PubMed 18559444Bagnardi V, Zatonski W, Scotti L, La Vecchia C, Corrao G. Does drinking pattern modify the effect of alcohol on the risk of coronary heart disease? Evidence from a meta-analysis. J Epidemiol Community Health. 2008 Jul;62(7):615-9. doi: 10.1136/jech.2007.065607.
- Results publication: PubMed 21616946Dahl H, Hammarberg A, Franck J, Helander A. Urinary ethyl glucuronide and ethyl sulfate testing for recent drinking in alcohol-dependent outpatients treated with acamprosate or placebo. Alcohol Alcohol. 2011 Sep-Oct;46(5):553-7. doi: 10.1093/alcalc/agr055. Epub 2011 May 26.
- Results publication: PubMed 12054359Dahl H, Stephanson N, Beck O, Helander A. Comparison of urinary excretion characteristics of ethanol and ethyl glucuronide. J Anal Toxicol. 2002 May-Jun;26(4):201-4. doi: 10.1093/jat/26.4.201.
- Results publication: PubMed 24773137Jatlow PI, Agro A, Wu R, Nadim H, Toll BA, Ralevski E, Nogueira C, Shi J, Dziura JD, Petrakis IL, O'Malley SS. Ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcohol Clin Exp Res. 2014 Jul;38(7):2056-65. doi: 10.1111/acer.12407. Epub 2014 Apr 28.
- Results publication: PubMed 17159008Di Castelnuovo A, Costanzo S, Bagnardi V, Donati MB, Iacoviello L, de Gaetano G. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006 Dec 11-25;166(22):2437-45. doi: 10.1001/archinte.166.22.2437.
- Results publication: PubMed 3390919Falk O, Palonek E, Bjorkhem I. Effect of ethanol on the ratio between testosterone and epitestosterone in urine. Clin Chem. 1988 Jul;34(7):1462-4.
- Results publication: PubMed 22111604Gaedigk A, Twist GP, Leeder JS. CYP2D6, SULT1A1 and UGT2B17 copy number variation: quantitative detection by multiplex PCR. Pharmacogenomics. 2012 Jan;13(1):91-111. doi: 10.2217/pgs.11.135. Epub 2011 Nov 23.
- Results publication: PubMed 20355168Grosse J, Anielski P, Sachs H, Thieme D. Ethylglucuronide as a potential marker for alcohol-induced elevation of urinary testosterone/epitestosterone ratios. Drug Test Anal. 2009 Nov;1(11-12):526-30. doi: 10.1002/dta.110.
- Results publication: PubMed 17558515Halter CC, Dresen S, Auwaerter V, Wurst FM, Weinmann W. Kinetics in serum and urinary excretion of ethyl sulfate and ethyl glucuronide after medium dose ethanol intake. Int J Legal Med. 2008 Mar;122(2):123-8. doi: 10.1007/s00414-007-0180-8. Epub 2007 Jun 9.
- Results publication: PubMed 16332934Jakobsson J, Ekstrom L, Inotsume N, Garle M, Lorentzon M, Ohlsson C, Roh HK, Carlstrom K, Rane A. Large differences in testosterone excretion in Korean and Swedish men are strongly associated with a UDP-glucuronosyl transferase 2B17 polymorphism. J Clin Endocrinol Metab. 2006 Feb;91(2):687-93. doi: 10.1210/jc.2005-1643. Epub 2005 Dec 6.
- Results publication: PubMed 16785338American Heart Association Nutrition Committee; Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael de la Torre, PhD principal investigator
IMIM-Hospital del Mar Medical Research Institute
José Antonio Pascual, PhD study chair
IMIM-Hospital del Mar Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 g ethanol, 20 g ethanol and Water in people with Alcohol Consumption and Healthy, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline steroid profile (time frame: From one day before administration till 24 hours after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869763, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.