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

Psoriasis Clinical Trial

— PCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045395
• Other study ID #: B2008:139
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2010
• Last updated: March 15, 2011
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2010
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Natural Health Products Directorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Psoriasis

Intervention

Dietary Supplement:
• Corn starch
90mg/d
• Unique Marine Algae Concentrate (UMAC)
90mg/d
• Golden brown algae
90mg/d

Locations

Country	Name	City	State
Canada	Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.		at the beginning and the end of each phase	No
Secondary	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	No