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 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT01045395
Eligibility Criteria:
Inclusion Criteria:
* Males and females with clinically diagnosed psoriasis
* Plasma LDL-C 80-190 mg/dL, and TG levels below 400 mg/dL.
* Body mass index (BMI) range will be 22 to 32 kg/m2.
* Subjects must demonstrate an ability to understand dietary procedures and be judged as compliant and motivated by the investigators.
* Subjects will be permitted to take stable doses of medications (including drugs for thyroid disease and hypertension)will be permitted if the dose level is maintained stable throughout the study.
* potential subjects must have stable psoriasis and their treatments must remain constant throughout the study.
Exclusion Criteria:
* recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo
* history of chronic use of alcohol (\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin
* subjects on anticoagulant therapy (such as warfarin), taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (\>4g/day), guggul, lecithin, evening primrose oil within the last six month period will be excluded. In addition, subjects will not be allowed to consume any of these medications during the study
* myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months
* recent onset and any history of angina, congestive heart failure, heart disease, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer
* moderate or high risk for CAD
* uncontrolled hypertension defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg
* pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* bleeding disorder, anemia, or significant recent blood loss/donation
* allergy/sensitivity to any of the ingredients in the study product or placebo
* chronic user of algal products, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01045395
Study Brief:
Protocol Section:
NCT01045395