Clinical trial NCT01045395: Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Official title: Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Algae
Psoriasis
Lipid metabolism
Inflammation
Oxidative stress
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: 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.
timeFrame: at the beginning and end of each of the three intervention periods
measure: Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.
timeFrame: at the beginning and the end of each phase
Secondary outcomes:
measure: 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.
timeFrame: at the beginning and the end of each phase
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
state: Manitoba
Study officials:
References: