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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT02366156
Eligibility Criteria:
Inclusion Criteria:
1. Subject is male or female, 18-70 years of age, inclusive.
2. Subject has a fasting TG concentration of ≥150 and \<500 mg/dL at visit 1b (week -1). One venous retest allowed for 145-149 and 500-550 mg/dL values.
3. Subject has a body mass index (BMI) of 25.00-34.99 kg/m2 at visit 1b (week -1).
4. Subject is willing to maintain habitual diet and physical activity patterns during the study period.
5. Subject has no plans to change smoking habits during the study period, and if a current smoker, subject is willing to refrain from all tobacco products for 1 h prior to all clinic visits in addition to up to 9 h during the test visits.
6. Subject has a score of 7 to 10 on the Vein Access Scale at screening visit (visit 1b, week -1).
7. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
8. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
1. Subject has abnormal laboratory test results of clinical significance at visit 1b (week -1), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to visit 2 (week 0), for subjects with abnormal laboratory test results.
2. Subject has a history or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders.
3. Subject has a history or current GI disorder that, in the judgment of the Investigator, may have the potential to disrupt normal digestion and absorption of dietary fats, including, but not limited to, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, significant lactose intolerance and/or egg allergy.
4. Subject has a known genetic predisposition to hyperlipidemia - as diagnosed by a health care professional.
Subject is a heavy smoker, defined as a history of smoking \>1 pack-per-day in the 3 months prior to visit 1b (week -1).
5. Subject has a history of difficulty swallowing tablets/capsules that could affect ability to consume the study product.Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
6. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
7. Subject has had a weight loss or gain \>4.5 kg in the 3 months prior to visit 1b (week -1).
8. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1b (week -1). One re-test will be allowed on a separate day prior to visit 2 (week 0), for subjects whose blood pressure exceeds either of these cut points, in the judgment of the Investigator.
9. Subject has not been on a stable dose of antihypertensive medication (at least 4 weeks prior to visit 1b, week -1 and for the duration of the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02366156
Study Brief:
Protocol Section:
NCT02366156