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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01768169
Eligibility Criteria:
Inclusion Criteria:
* Age 30 to 65 years
* Female subjects must have a negative pregnancy test at screening, must be surgically sterile or at least 6 months postmenopausal or must use a form of birth control measure.
* BMI of 24 to 40 kg/m2 inclusive.
* Subjects must be in good health other than having metabolic syndrome as determined by medical history, physical examination, and screening clinical laboratory including chemistry panel and CBC.
* Must have stable smoking habits (or be now-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
* Subjects requiring the regular use of any prescription medication may be admitted to the study providing the dose is stable.
* Ethical subjects only will be admitted who are likely to comply with all visits and instructions. This will be determined in the screening phase.
* Body weight must be stable within 2% of change in the last 3 months.
* Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Exclusion Criteria:
* Diabetes
* nown or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
* Angina or other chest pain that may indicate CHD
* Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
* Known abnormal liver function tests greater than 3X upper limit of normal
* Smoker, illicit drug use, or excessive alcohol use
* Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
* Pregnancy or planning pregnancy during the study period
* Sensitivity or allergy to fish
* Subjects who had undergone bypass procedure.
* Any debilitating disease such as tuberculosis, HIV etc.
* Unwillingness to give written informed consent for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01768169
Study Brief:
Protocol Section:
NCT01768169