Healthy Volunteers Clinical Trial
Official title:
Effect of Tea Consumption on Steroid Profile in Healthy Volunteers. Pilot Study
Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid profile after green tea consumption.
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.
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