Effect of Tea Consumption on Steroid Profile in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02779361|
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Doping in Sports||Dietary Supplement: Green tea||Phase 1|
Anabolic androgenic steroids are included in the list of banned substances in sports by the World Anti-Doping Agency (WADA) because of its ability to improve the performance of athletes.
Testosterone glucuronization by UGT2B17 isoenzyme (Uridine Diphosphate Glucuronyltransferase 2B17) is inhibited in vitro by green tea flavonols like epicatechin, epigallocatechin gallate (EGCG) and catechin gallate.
Therefore a diet rich in green tea could interfere in androgens' glucuronization and cause a change on the steroid profile of the athletes that could be considered a false positive.
A clinical trial designed to assess changes on steroid profile in healthy volunteers after green tea consumption will be conducted. Subjects with different UGT2B17 genotype will be recruited (10 of each type: ins/ins, ins/del, del/del) to study if the genotype can modulate the results obtained.
Urine samples obtained before and during 7 days of green tea consumption will be used to compare steroid profile. Blood samples will be also collected to assess EGCG pharmacokinetics.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Tea Consumption on Steroid Profile in Healthy Volunteers. Pilot Study|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||February 14, 2017|
|Actual Study Completion Date :||February 14, 2017|
Experimental: Green tea
Green tea consumption along 7 days.
Dietary Supplement: Green tea
Lipton pure green tea, 5 teas on the first 6 days, and 9 teas on the day 7. Teas will be ingested at 08:00 am, 10:30 am, 13:00 pm, 15:30 pm, 18:00 pm days 1-6, and 08:00 am (*), 10:30 am, 13:00 pm (*), 15:30 pm, 18:00 pm (*), 20:30 pm on day 7.
One bag of tea will be used to prepare the beverages with exception of some beverages on day 7 that will be prepared with two bags (*).
- Steroid profile in urine [ Time Frame: From 3 days before consumption (day -3,-2,-1) till day 8 (day 1-8) after consumption ]24 hours urine will be collected.
- Epigallocatechin gallate (EGCG) blood concentrations [ Time Frame: Baseline and day 7 ]One sample before tea administration (day -1) and 3 samples on day 7 (before, 1hour and 2 hours after first tea on day 7).
- Serious and non serious adverse events [ Time Frame: From inclusion till day 9 (final visit) ]Adverse events reported by subjects and interrogated by investigators will be collected.
- UGT2B17 Genotype [ Time Frame: Baseline ]Sample for pharmacogenetics will be obtained before tea administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779361
|Parc de Salut Mar-IMIM|
|Barcelona, Spain, 08003|
|Study Director:||Rosa Ventura, PhD||World Anti-doping Agency|