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:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT03867812
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-lactating females, 25-65 years of age, inclusive
* Body mass index 20 - 30 kg/m2 inclusive
* Blood pressure: systolic \< 140 and diastolic \<95 mmHg.
* Social drinkers; average 2 or fewer drinks per day and have not had an episode of "binge drinking" over the previous 30 days. Binge drinking is defined has having 4 or more drinks (for women) / 5 or more drinks (for men) over the course of 2 hours. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz. of distilled 80-proof spirit.
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and consume the standard meal provided by GI Labs the evening before each test day
* Subject is willing to abstain from strenuous exercise, alcoholic drinks, and cannabis use 24hours before study visits.
* Subject is willing to refrain from driving or operating any vehicle when leaving GI Labs after the test visit
* Subject is willing to sign on each test day a statement acknowledging that the subject is aware that he/she has consumed alcohol that morning
* Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements or caffeine. Failure to comply will result in a rescheduled test visit.
* No major illness or surgery requiring hospitalization within 3 months of the first study visit after screening.
* No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease.
* Subjects must be eligible to receive income in Canada and be covered by a health insurance such as OHIP.
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
* Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period. Willing to take a urine pregnancy test the day of each study.
Exclusion Criteria:
* Failure to meet all the inclusion criteria
* Smoker
* Known history of gastrointestinal, liver, kidney, or cardiovascular (including but not limited to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), and pulmonary disease
* History of mental disease, seizures, use or abuse of psychoactive medications (including but not limited to cocaine, amphetamines, opiates, sedatives, benzodiazepines, and hallucinogens) or any medication or condition which might, in the opinion of Dr. Wolever, the medical director of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Use of antibiotics within 4 weeks of start of study.
* History or diagnosis of alcohol use disorder or binge drinking (4 or more drinks for women and 5 or more drinks for men within a 2-hour window) as defined by the current NIAAA guidelines.
* Major trauma or surgical event within 3 months of screening.
* Of East Asian descent or having a history of alcohol induced flushing reaction.
* Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
* Change in body weight of \>3.5kg within 4 weeks of the screening visit.
* Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
* History of cancer in the prior two years, except for non-melanoma skin cancer.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT03867812
Study Brief:
Protocol Section:
NCT03867812