NCT02779361

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

May 18, 2016

Last Update Submit

July 26, 2017

Conditions

Healthy VolunteersDoping in Sports

Keywords

green teasteroid profile

Outcome Measures

Primary Outcomes (1)

  • Steroid profile in urine

    24 hours urine will be collected.

    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

    Baseline and day 7

  • Serious and non serious adverse events

    From inclusion till day 9 (final visit)

  • UGT2B17 Genotype

    Baseline

Study Arms (1)

Green tea

EXPERIMENTAL

Green tea consumption along 7 days.

Dietary Supplement: Green tea

Interventions

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 (\*).

Green tea

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Individuals intolerant or having experienced a severe adverse reaction to green tea or caffeine
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc de Salut Mar-IMIM

Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rosa Ventura, PhD

    World Anti-Doping Agency

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

January 1, 2016

Primary Completion

February 14, 2017

Study Completion

February 14, 2017

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)