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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Dietary Supplement: Corn starch
* Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
* Dietary Supplement: Golden brown algae


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Corn starch, 90mg/d<br>Corn starch, 90mg/d | Dietary Supplement: Corn starch<br>* 90mg/d<br>|
| Experimental: Unique Marine Algae Concentrate (UMAC). 90mg/d<br> | Dietary Supplement: Unique Marine Algae Concentrate (UMAC)<br>* 90mg/d<br>|
| Experimental: Golden brown algae, 90mg/d<br> | Dietary Supplement: Golden brown algae<br>* 90mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | at the beginning and end of each of the three intervention periods | 
| Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined. |  | at the beginning and the end of each phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | at the beginning and the end of each phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress