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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT02010359
Eligibility Criteria:
Inclusion Criteria:
1. Men and non-pregnant/lactating women between the ages of 25 and 50.
2. Body Mass Index (BMI) ≥30 kg/m2
3. Participants who are able to give written informed consent and willing to comply with all study-related procedures.
Exclusion Criteria:
1. Diabetes Mellitus (glucose fasting \>126, or random \>200, Hemoglobin A1C\>6.5 %, or use of any anti-diabetic agent)
2. Self-reported fish or shellfish allergy
3. Planned usage of any prescription or non-prescription medication (other than contraceptive pills or devices) during the study period.
4. Recent (within 6 months) use of fish oil supplements or self- reported dietary intake of \>3 servings of fish/month
5. Blood pressure \>140/90
6. Recent (within 6 months) use of statins, niacin, or fenofibrates
7. Current or planned pregnancy/lactation. Pre-menopausal women unwilling to prevent pregnancy by use of the following approved contraceptive strategies: diaphragm, cervical cap, condom with spermicide, surgical sterility, birth control pills, Depo-Provera injection, Intra-uterine device, progestin implant, or abstinence.
8. History of liver disease or abnormal liver function tests (aspartate aminotransferase, Alanine transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase \> 1.5x Upper Limit normal; bilirubin \> 2x upper limit normal) at Screening Visit
9. Men who are unwilling to limit alcohol consumption to \< 14 alcoholic drinks per week or \< 4 alcoholic drinks per occasion while participating in the study
10. Women who are unwilling to limit alcohol consumption to \< 7 alcoholic drinks per week or \< 3 alcoholic drinks per occasion while participating in the study.
11. Hemoglobin less than 11.0 g/dL
12. Any reported arrhythmia, usage of anti-arrhythmic therapy, or abnormal screening electrocardiogram
13. Known bleeding disorder or coagulopathy
14. Any major active rheumatologic, pulmonary, hematologic or dermatologic disease or inflammatory condition or minor active infection
15. Self-reported history of HIV positive
16. Patients who have undergone any organ transplant
17. Individuals who currently use tobacco products or have done so in the previous 30 days
18. Treatment with aspirin, non steroidal anti-inflammatories, COX-2 inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit
19. Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements and/or fortified food, or have their usual intake of high omega-3 fish (tuna and other non-fried fish) be \> 3 to 4 servings per month as assessed by a simple screening questionnaire
20. Recent (within 6 months) treatment with coumarin-type anticoagulants
21. Positive urine pregnancy test result.
22. Self-reported history of injected recreational drug use.
23. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT02010359
Study Brief:
Protocol Section:
NCT02010359