Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis (PCA)

This study has been completed.

Sponsor:

Information provided by:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT01045395

First received: January 7, 2010

Last updated: March 15, 2011

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2010
Last Updated Date	March 15, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2010)	A photographic documentation will be carried out quantifying lesion size over at least two body sites. A subjective questionnaire will also be provided to volunteers to enable self-reported evaluation of the extent and degree of discomfort of lesions. [ Time Frame: at the beginning and end of each of the three intervention periods ] [ Designated as safety issue: No ] Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01045395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 8, 2010)	Vascular cell adhesion molecule-1 (VCAM-1), E-selectin, interleukin-6 (IL-6), IL-10, soluble tumour necrosis factor receptor 2 (sTNFR-2) and soluble cell adhesion molecules (sICAM-1 and sVCAM-1) will be assessed. Lipid peroxidation will also be measured. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Official Title ^ICMJE	Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Brief Summary	Our overall goal is to evaluate the safety and efficacy of consumption of two algae formulations compared to a placebo on: degree of severity of skin lesions, plasma lipid levels, as well as other health-related markers, in individuals with clinically diagnosed psoriasis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	Dietary Supplement: Corn starch 90mg/d Dietary Supplement: Unique Marine Algae Concentrate (UMAC) 90mg/d Dietary Supplement: Golden brown algae 90mg/d
Study Arm (s)	Placebo Comparator: Corn starch, 90mg/d Corn starch, 90mg/d Intervention: Dietary Supplement: Corn starch Experimental: Unique Marine Algae Concentrate (UMAC). 90mg/d Intervention: Dietary Supplement: Unique Marine Algae Concentrate (UMAC) Experimental: Golden brown algae, 90mg/d Intervention: Dietary Supplement: Golden brown algae
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date	November 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01045395
Other Study ID Numbers ^ICMJE	B2008:139
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Peter Jones Director Richardson Centre for Functional Foods and Nutraceuticals, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Study Sponsor ^ICMJE	University of Manitoba
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Manitoba
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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