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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
29
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 (\*).
Parc de Salut Mar-IMIM
Barcelona, Spain
Steroid profile in urine
24 hours urine will be collected.
Time frame: From 3 days before consumption (day -3,-2,-1) till day 8 (day 1-8) after consumption
Epigallocatechin gallate (EGCG) blood concentrations
One sample before tea administration (day -1) and 3 samples on day 7 (before, 1hour and 2 hours after first tea on day 7).
Time frame: Baseline and day 7
Serious and non serious adverse events
Adverse events reported by subjects and interrogated by investigators will be collected.
Time frame: From inclusion till day 9 (final visit)
UGT2B17 Genotype
Sample for pharmacogenetics will be obtained before tea administration
Time frame: Baseline
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