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

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01045395
First received: January 7, 2010
Last updated: March 15, 2011
Last verified: January 2010

January 7, 2010
March 15, 2011
September 2009
June 2010   (final data collection date for primary outcome 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. [ Time Frame: at the beginning and end of each of the three intervention periods ] [ Designated as safety issue: No ]
  • Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045395 on ClinicalTrials.gov Archive Site
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. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Psoriasis
  • Dietary Supplement: Corn starch
    90mg/d
  • Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
    90mg/d
  • Dietary Supplement: Golden brown algae
    90mg/d
  • Placebo Comparator: Corn starch, 90mg/d
    Corn starch, 90mg/d
    Intervention: Dietary Supplement: Corn starch
  • Experimental: Unique Marine Algae Concentrate (UMAC). 90mg/d
    Intervention: Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
  • Experimental: Golden brown algae, 90mg/d
    Intervention: Dietary Supplement: Golden brown algae
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01045395
B2008:139
Yes
Dr. Peter Jones Director Richardson Centre for Functional Foods and Nutraceuticals, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP