Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02779361
Brief Summary:
Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid profile after green tea consumption.
Detailed Description:
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:
NCT02779361
Study Brief:
Protocol Section:
NCT02779361