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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01803594
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years
* Plasma HDL cholesterol (Less than 50 mg/dL)
Exclusion Criteria:
* History of gastrointestinal disorders like Crohns disease, colitis, irritable bowel syndrome
* History of cardiovascular events: stroke, heart attack, cardiac arrhythmia
* History of peptic ulcers, gastritis
* History of gout
* History of being under care of any psychiatric conditions (schizophrenia and depression associated with response to niacin)
* Cancer
* Type 1 or 2 diabetes
* Known presence of significant metabolic disease which could impact results of study (hepatic, renal disease)
* Low blood pressure (defined as 3 consecutive readings below 100/60 mmHg at screening)
* Self report skin sensitivities; self report to rash easily
* Self report to hot flashes currently experience due to menopause
* Hypersensitivity to niacin
* Muscle disorders such as myasthenia gravis
* Pending surgery within the next 3 months
* Known allergy to study food (shellfish, fish, nut, soy)
* Known intolerance to study food (lactose intolerance)
* More than 1 serving of fish per week
* Intake of anti-inflammatory supplemental fish, krill, borage, flax, and primrose seed oils within the last 12 weeks
* Intake of dietary supplements consisting of concentrated soy isoflavones, resveratrol, other dietary polyphenols identified as modulators of lipids within the last 12 weeks
* Intake of more than 20 mg of lutein and zeaxanthin per week
* Intake of nicotinic acid (niacin) within the last 12 weeks
* Intake of anti-coagulants, blood pressure or heart medications within the last 12 weeks
* Plan to become pregnant in next 6 months
* Recent initiation (past 4 weeks) of exercise program
* Use of tobacco products
* Excessive alcohol consumption (2 drinks/day for men and 1 drink/day for women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01803594
Study Brief:
Protocol Section:
NCT01803594