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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT03528603
Eligibility Criteria:
Inclusion Criteria:
* Trials 1 and 2: Male; Trial 3: Male and Female
* 20-45 years old
* For females, a regular 25-30-day menstrual cycle
* Subject is willing and able to comply with the study protocols
* Subject is willing to drink 40 mL (approximately 2 tablespoons) of olive oil
* BMI 18.5 - 30 kg/m2
* Weight ≥ 110 pounds
Exclusion Criteria:
* Adults who are not able to consent
* BMI ≥ 31 kg/m2
* Under current medical supervision
* 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%.
* Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the UCD Med Center
* Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.
* Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS
* Females using hormonal contraception
* Ibuprofen intolerance or allergy
* Those with a bleeding disorder
* Non-English speaking
* Allergy to olives or olive oil
* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, or on a weight loss diet.
* A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
* Currently taking prescription drugs or supplements
* Indications of substance or alcohol abuse within the last 3 years
* Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements for six weeks prior to study enrollment.
* Not willing to refrain from olive oil consumption for 4 weeks prior to study enrollment, and throughout study enrollment
* Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
* Current enrollee in a clinical research study.
* Individuals with blood clotting or platelet defect disorders
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03528603
Study Brief:
Protocol Section:
NCT03528603