Healthy VolunteersPhase 1NCT02779361
Effect of Tea Consumption on Steroid Profile in Healthy Volunteers
A Phase 1 study testing Green tea in people with Healthy Volunteers and Doping in Sports, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid profile after green tea consumption. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Doping in Sports
- What is being tested?
- Green tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to 14 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Green tea
- Keywords
- green tea, steroid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
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 (*).
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Green tea consumption along 7 days. Receives: Dietary Supplement: Green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid profile in urine
24 hours urine will be collected.
Measured: From 3 days before consumption (day -3,-2,-1) till day 8 (day 1-8) after consumption
Secondary outcomes (3)
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).
Measured: Baseline and day 7
Serious and non serious adverse events
Adverse events reported by subjects and interrogated by investigators will be collected.
Measured: From inclusion till day 9 (final visit)
UGT2B17 Genotype
Sample for pharmacogenetics will be obtained before tea administration
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2016
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- World Anti-Doping Agency
- Responsible party
- Principal investigator, Clara Pérez, Parc de Salut Mar
- Investigators
- Rosa Ventura, PhD, Study director, World Anti-Doping Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779361
- Sponsor's protocol ID
- IMIMFTCL/EGCG/3
- Status last verified
- Jul 2017
- First submitted
- 18 May 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tea Consumption on Steroid Profile in Healthy Volunteers. Pilot Study
- ClinicalTrials.gov ID
- NCT02779361
- Acronym / sponsor ID
- IMIMFTCL/EGCG/3
- Conditions
- Healthy Volunteers, Doping in Sports
- Keywords
- green tea, steroid profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- World Anti-Doping Agency
- Study start
- Jan 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Green tea | Experimental | Dietary Supplement: Green teaGreen tea consumption along 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green teaLipton 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 (*). | Dietary supplement | Green tea |
Primary outcome
Steroid profile in urine
Time frame: From 3 days before consumption (day -3,-2,-1) till day 8 (day 1-8) after consumption
24 hours urine will be collected.
3 secondary outcomes
Epigallocatechin gallate (EGCG) blood concentrations
Time frame: Baseline and day 7
Serious and non serious adverse events
Time frame: From inclusion till day 9 (final visit)
UGT2B17 Genotype
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Ventura, PhD study director
World Anti-Doping Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Green tea in people with Healthy Volunteers and Doping in Sports, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid profile in urine (time frame: From 3 days before consumption (day -3,-2,-1) till day 8 (day 1-8) after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.