Psoriasis
Conditions
Keywords
Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress
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.
Interventions
DIETARY_SUPPLEMENTCorn starch
90mg/d
DIETARY_SUPPLEMENTUnique Marine Algae Concentrate (UMAC)
90mg/d
DIETARY_SUPPLEMENTGolden brown algae
90mg/d
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada
Outcome results
None listed