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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Dietary Supplement: Golden brown algae; Dietary Supplement: Corn starch; Dietary Supplement: Unique Marine Algae Concentrate (UMAC)

• Registration Number: NCT01045395
• Lead Sponsor: University of Manitoba

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 available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-06
• Study Completion: 2010-11
• Last Update Submitted: 2011-03-15
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Golden brown algae, 90mg/d	Golden brown algae	-
Corn starch, 90mg/d	Corn starch	Corn starch, 90mg/d
Unique Marine Algae Concentrate (UMAC). 90mg/d	Unique Marine Algae Concentrate (UMAC)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M; 🇨🇦 Winnipeg, Manitoba, Canada