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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT05401604
Eligibility Criteria:
Inclusion Criteria:
* Ability to give informed consent.
* 21 - 60 years of age (inclusive) at screening.
* Healthy male, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Race must be Chinese.
* Willing to consume 1 beer can per day for 14 days.
* Not on any regular medications (western/ traditional).
* No family history of alcoholism.
Exclusion Criteria:
* Female.
* A current smoker, have smoked, or is a user of tobacco products for the past 2 years.
* History or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data.
* History of alcoholism, alcohol dependence, alcohol abuse, alcohol allergy and/or any other alcohol use disorders.
* History of Type 1/ Type 2 diabetes and use of anti-diabetic medications in the past.
* Regular use of medication that are known to have an effect on immune function.
* Regular use of aspirin.
* A naïve alcohol drinker.
* Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to first visit of the study.
* Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study.
* Significant change in weight (+/- 5%) during the past month.
* Antibiotic use in the past 2 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05401604
Study Brief:
Protocol Section:
NCT05401604