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:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT00267904
Eligibility Criteria:
* INCLUSION CRITERIA:
The subjects are healthy volunteers 18 years or older who are not pregnant or lactating.
EXCLUSION CRITERIA:
\<TAB\>
Minors younger than 18 years old are excluded.
A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. A candidate subject is excluded if, in the opinion of the Principal Investigator, the medical risk outweighs the potential scientific benefit.
A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are hepatic failure, a history of tachyarrhythmias or heart block, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, symptomatic coronary heart disease, diabetes mellitus, or hyperthyroidism. Abnormal screening results may exclude further participation, at the discretion of the Principal Investigator.
Subjects will be excluded from further participation and referred for medical management, if the systolic blood pressure during supine rest is greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 105 mm Hg.
Alcohol use disorder.
A candidate subject is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results. Examples are acetaminophen, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, adrenoceptor agonists or antagonists, anticoagulants, anticonvulsants, antipsychotics, calcium channel blockers, hypoglycemic agents, digoxin, dopaminergic drugs, monoamine oxidase inhibitors, oral contraceptives, sedatives, steroids, and tricyclic antidepressants. Patients are not to discontinue any medications, just to participate in this study.
Subjects in whom we feel it would be difficult to insert a catheter into a vein may be excluded.
Pregnant or lactating women are excluded. To exclude pregnancy, women with child bearing potential have blood testing for pregnancy, with negative results obtained within 1 day of each day of testing.
Candidate subjects who admit to a history of alcohol addiction and alcohol use disorder are excluded from the study as a whole, but is especially important in the portion of the study involving ingesting red wine.
Candidate subjects who drink alcohol every day are excluded from the portion of the study involving ingesting red wine.
People with a history of sulfite allergy are excluded from the portion of the study involving ingestion of red wine.
Subjects must be at least 21 years old in order to participate in the portion of the study involving ingestion of red wine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00267904
Study Brief:
Protocol Section:
NCT00267904