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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02322203
Eligibility Criteria:
* INCLUSION CRITERIA:
* Males and females who are at least 18 years of age at time of enrollment.
* Subject understands the investigational nature of the study and provides written, informed consent.
EXCLUSION CRITERIA:
* Subjects taking any lipid modification therapy, including but not limited to statins, fibrates and bile acid sequestrants.
* Subjects taking fish oil or any other supplements, which in the investigator s opinion may interfere with the study.
* Subjects with acute liver disease or active peptic ulcer disease.
* Subjects with elevated uric acid levels greater than 10 mg/dL or gout
* Pregnancy or women currently breastfeeding.
* Female subjects taking hormonal contraceptives or hormone replacement therapy may be included in this study only if they have been on a stable dose for at least 3 months.
* BMI less than 18.5
* Subjects with weight that varies greater than 20% over the past 3 months.
* Subjects taking the following medications for at least six weeks, which may interfere with the study, will be excluded: BAS, antibiotics, anticoagulants, anticonvulsants, antiarrhythmic, Cyclosporine, Mycophenolate and Synthroid. Subjects with chronic diarrhea, gastric bypass or lap band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
* Subjects initiating new medications or patients on multiple medications may also be excluded.
* Inability to swallow capsules
* Patients with a history of type I or type II diabetes or HbA1c greater than 6.5%.
* Volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02322203
Study Brief:
Protocol Section:
NCT02322203