NCT02869763

Dose-response Effect of Alcohol Ingestion on Steroid Profile

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Alcohol Consumption
• Healthy

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-11-01
• Completion: 2017-09-01
• First posted: 2016-08-17
• Last updated: 2017-10-06

Locations

1 site across 1 country: Spain