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 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT03937206
Eligibility Criteria:
Inclusion Criteria:
* Adults 18 years to 80 years (inclusive) at time of screening with suitable veins for cannulation or repeated venipuncture.
* BMI ≥ 18.5 to ≤ 34.9 kg/m2 at the time of Screening
* Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative urine pregnancy test and must be using an effective birth control method, defined as:
* Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or
* Use of an intra-uterine device or implantable contraceptive, or
* Use of double barrier methods of birth control, or
* Abstinence from heterosexual intercourse
* Willing to avoid alcohol consumption for 24 h prior to every clinic visit
* Willing to avoid moderate to intense exercise 24 h prior to every clinic visit
* Consume less than 200 mg omega-3 per day based on validated Questionnaire
* Agrees to stop taking any vitamins, minerals, or any fatty acid containing dietary/herbal supplements that could potentially interfere with the study endpoints and will be washed out for two weeks prior to study product administration and throughout the study.
* Willing to maintain a stable diet and level of activity throughout the trial.
* Willing to keep a daily journal describing impact of dosage and tolerability.
* Able to comply with all protocol activities.
* Willing and able to provide informed written consent.
Exclusion Criteria:
* Consumption of fish within two weeks prior to the first investigational product administration and for the duration of the study.
* Used canola oil, fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements within one (1) month of baseline (Visit 2) or any time during the study, other than the product being evaluated in this study.
* Have a known sensitivity or allergy to canola or any other ingredients in the test products.
* Individuals taking prescription or non-prescription health products that may affect the study endpoint (e.g. corticosteroids, prescription anti-inflammatory drugs, blood lipid-lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, etc.) in the previous 6 months.
* Individuals taking any supplements with phytosterols, polyglucosamines (Chitosan) or other lipid-binding ingredients in the previous 3 months.
* Unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1.
* Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study.
* Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study.
* History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin).
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).
* Presence of major diseases such as diabetes, endocrine, cardiovascular, renal, or liver disease.
* History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.).
* History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years.
* Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
* Active psychiatric disease (hospitalized within the past 12 months of Screening).
* Documented medical history of immune disorder (such as HIV/aids, hepatitis B or hepatitis C) or positive laboratory results within 28 days of dosing.
* History of a surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding).
* Taking potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin and nefazodone) within two weeks prior to first investigational product administration and throughout the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03937206
Study Brief:
Protocol Section:
NCT03937206