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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01048502
Eligibility Criteria:
Inclusion Criteria:
* Men and non-pregnant/lactating women between the ages of 18 and 45.
* Body Mass Index (BMI) ≥18 and ≤30
* Participants who are able to give written informed consent and willing to comply with all study-related procedures.
Exclusion Criteria:
* Known clinically manifest atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
* History of diabetes mellitus
* Fasting glucose \>126mg/dL at screening
* History of a non-skin malignancy within the previous 5 years
* Renal insufficiency as defined by creatinine outside of lab defined normal range or eGFR \<60 ml/Kg/min at Screening Visit
* History of liver disease or abnormal Liver Function Tests (LFTs) (aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma-glutamyl transpeptidase (GGT) \> 1.5x upper limit of normal (ULN); bilirubin \> 2x ULN) at Screening Visit
* Men who are unwilling to limit alcohol consumption to \< 14 alcoholic drinks per week or \< 4 alcoholic drinks per occasion (American Medical Association/National Institute on Alcohol Abuse and Alcoholism (AMA / NIAAA) criteria for "at risk" usage levels) while participating in the study
* Women who are unwilling to limit alcohol consumption to \< 7 alcoholic drinks per week or \< 3 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage levels) while participating in the study
* Total white blood cell count less than or equal to 3.0 THO/uL
* Hemoglobin less than 11.0 g/dL
* Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection
* Self-reported history of HIV positive
* First degree family history of premature cardiovascular disease event (father or brother if diagnosed at before 55 years of age; mother or sister if diagnosed before 65 years of age)
* Patients who have undergone any organ transplant
* Individuals who currently use tobacco products or have done so in the previous 30 days
* Treatment with aspirin, Nonsteroidal Anti-inflammatory Drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit
* Treatment with statins, fibrates or niacin 4 weeks prior to the Screening Visit.
* Current daily use of Vitamin C \> 1000 mg, Beta carotene \> 1000 IU, vitamin A \> 5000 IU, vitamin E \> 400 IU, and selenium \> 200 mcg
* Participants who are unwilling to eliminate omega-3 fatty acid (eicosapentaenoic acid (EPA) + docosahexaenoic acid (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
* Positive urine pregnancy test result.
* Participation in another clinical trial within the previous 6 weeks prior to the Screening Visit.
* Poorly controlled blood pressure (BP \> 160/110) or on any anti-hypertensive medications.
* A diagnosis of metabolic syndrome using updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) criteria.
* Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01048502
Study Brief:
Protocol Section:
NCT01048502