Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT03614520
Eligibility Criteria:
Inclusion Criteria:
* Men and women from 18 to 45 years old.
* Understand and accepting the procedures of the trial and sign an informed consent.
* Have a history and physical exams that show that there is no organic issue, and an analysis and ECG in the normal limits.
* Have an BMI between 18.5 and 30 kg/m2.
* caucasian race
Exclusion Criteria:
* Smokers
* Persons with chronical disease
* Persons with BMI\>30 or \<18.5 kg/m2.
* Persons with history of multiple allergies or obvious intestinal, hepatic, renal issues or other problems that could suppose a deterioration of absorption, distribution or metabolism of polyphenols.
* Persons who take anti-oxidant products, including vitamins, herbal medication or dietetics complementation that could interfere in the study objectives.
* Persons with restrictive diet (including vegetarian diet).
* Persons with history of hypersensibility or intolerance to alcohol.
* Persons with a daily consumption of alcohol \>50g or who have consumed illegal drug in the month preceding the study.
* Persons who have participated in an other clinical trial the month preceding the study.
* Persons who have done a blood donation during the last 3 months before the beginning of the study (only appliable to the subjects of A sub-study).
* Persons who have a positive serology for B or C hepatitis or HIV.
* Pregnant or breastfeeding women, or any other situation prohibiting alcohol consumption.
* Persons who have consummed NSAIDs (especially acetylsalicylic acid) or antioxidants or vitamin complementation, during the 2 weeks preceding the beginning of the study.
* Illiterate persons
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03614520
Study Brief:
Protocol Section:
NCT03614520