Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid
profile after green tea consumption.
: Green tea
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Full eligibility criteria for NCT02779361
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
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)
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
All locations for NCT02779361
Parc de Salut Mar-IMIM
Barcelona, Spain, 08003
View full eligibility
Tris trial is registered with FDA with number: NCT02779361. The sponsor of the trial is Parc de Salut Mar and it is looking for 29 volunteers for the current phase.
Official trial title: Effect of Tea Consumption on Steroid Profile in Healthy Volunteers. Pilot Study
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