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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT03523403
Eligibility Criteria:
Inclusion Criteria:
* 18 - 75 years old
* BMI ≥ 25 kg/m2 and/or waist circumference ≥ 40" for males or ≥ 30" for females
* Current/prior use of acetaminophen without complications
Exclusion Criteria:
* Pregnant or breastfeeding females
* Fasting blood glucose ≥ 7.0 mmol/L
* Chronic diseases, including by not limited to: type 2 diabetes, cardiovascular disease, liver disease, etc.
* Gastrointestinal conditions or illnesses, including but not limited to: lactose intolerance, Celiac disease, Crohn's disease, Ulcerative Colitis, Irritable Bowel Disorder
* Inflammatory conditions or active infection
* Serious major medical condition requiring hospitalization within the last year
* Taking any prescription medications (including hormonal contraceptives) or over the counter medications prescribed by a medical professional
* Taking any natural health products or dietary supplements, other than a multivitamin low in phenolic acids
* Taking any medication or natural health product contraindicated with acetaminophen
* Allergy to acetaminophen
* Use of immunomodulating agents
* Antibiotic use within last 3 months
* Alcohol consumption of ≥ 4 drinks/sitting or ≥ 14 drinks/week
* Use of tobacco products or recreational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03523403
Study Brief:
Protocol Section:
NCT03523403