NCT02779361

Effect of Tea Consumption on Steroid Profile in Healthy Volunteers

Effect of Tea Consumption on Steroid Profile in Healthy Volunteers. Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Doping in Sports

Interventions

Type	Name	Description
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 (\*).

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-14
• Completion: 2017-02-14
• First posted: 2016-05-20
• Last updated: 2017-07-28

Locations

1 site across 1 country: Spain