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 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT01690312
Eligibility Criteria:
Inclusion Criteria:
* Be an adult between the ages of 18 and 70;
* Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;
* Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement \[and whom have reached a target LDL level\];
* Have elevated fasting triglyceride levels \[greater than 1.5 mmol/L but less than 5.7 mmol/L\];
* Have fasting blood glucose levels below the study cut-off \[less than 7.0 mmol/L\];
* Have a Body Mass Index (BMI) less than 35.0
* Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.
Exclusion Criteria:
* Be younger than 18 years of age or older than 70 years of age;
* Be an adult pre- or peri-menopausal female;
* Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;
* Have fasting triglyceride levels outside of study limits\[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L\];
* Have elevated fasting blood glucose levels \[greater or equal to 7.0 mmol/L\];
* Have high blood pressure \[greater than 140/100\]
* Have a Body Mass Index (BMI) equal to or greater than 35.0
* Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack;
* Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;
* Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement;
* Consume more than two (2) fish meals on a weekly basis
* Consume excessive amounts of alcohol on a weekly basis \[more than 10 alcoholic drinks per week\];
* Anticipate or have planned surgery during the course of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01690312
Study Brief:
Protocol Section:
NCT01690312