Effect of Tea Consumption on Steroid Profile in Healthy Volunteers

Parc de Salut Mar

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Doping in Sports

Treatments

Dietary Supplement: Green tea

Study type

Interventional

Funder types

Other

Identifiers

NCT02779361

IMIMFTCL/EGCG/3

Details and patient eligibility

About

Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid profile after green tea consumption.

Full 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.

Enrollment

29 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Understand and accept the study's procedures and sign an informed consent form
Body mass index (BMI=weight/heigth2) between 19 and 27 kg/m2, weight between 50 and 100 kg.
No evidence of somatic or psychiatric disorders as per past medical history and physical examination
EKG, blood and urine tests taken before entry into the study within the normal range. Minor and transient abnormalities may be acceptable if, according to the Principal Investigator's criterion and the state of the art, they are felt to have no clinical relevance, entail no danger to the participant, and don't interfere with the product's assessment. These abnormalities and their non-relevance must be specifically justified in writing)

Exclusion criteria

Evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of the drug or symptoms suggestive of drug-induced gastrointestinal irritation
Previous psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs
Having donated blood or having participated in this same study in the preceding 8 weeks, or having participated in any clinical trial with drugs in the preceding 12 weeks
Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial
Individuals intolerant or having experienced a severe adverse reaction to green tea or caffeine
Having regularly taken medication in the month before the trial, except for vitamins, herb-based remedies, dietary supplements that if, according to the Principal Investigator or his appointed collaborators' opinion, they pose no threat to the subjects and they won't interfere with the study's objectives. Single doses of symptomatic drugs taken during the week before the experimental session will not constitute an exclusion criterion if it can be assumed that it has been completely eliminated on the day of the experimental session
Smokers of >10 cigarettes/day
Consumption of >40 g/day of alcohol
Daily consumption of less than one xanthine-containing beverages per day
Hepatitis B, hepatitis C or human immunodeficiency virus-positive individuals
Vegetarian subjects or with aberrant diets