Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
NCT ID: NCT01045395
Last Updated: 2011-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-09-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Corn starch, 90mg/d
Corn starch, 90mg/d
Corn starch
90mg/d
Unique Marine Algae Concentrate (UMAC). 90mg/d
Unique Marine Algae Concentrate (UMAC)
90mg/d
Golden brown algae, 90mg/d
Golden brown algae
90mg/d
Interventions
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Corn starch
90mg/d
Unique Marine Algae Concentrate (UMAC)
90mg/d
Golden brown algae
90mg/d
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Locations
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Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2008:139
Identifier Type: -
Identifier Source: org_study_id
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