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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Dietary supplement: Corn starch; Dietary supplement: Unique Marine Algae Concentrate (UMAC); Dietary supplement: Golden brown algae

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Corn starch, 90mg/d	Dietary supplement: Corn starch; 90mg/d
Experimental: Unique Marine Algae Concentrate (UMAC). 90mg/d	Dietary supplement: Unique Marine Algae Concentrate (UMAC); 90mg/d
Experimental: Golden brown algae, 90mg/d	Dietary supplement: Golden brown algae; 90mg/d

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 16, 2011
• Last Update Submitted That Met QC Criteria: March 15, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Psoriasis; Lipid metabolism; Algae
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Inflammation; Psoriasis
• Other Study ID Numbers: B2008:139