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
  Purpose

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.


Condition Intervention Phase
Psoriasis
Dietary Supplement: Corn starch
Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
Dietary Supplement: Golden brown algae
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Corn starch, 90mg/d
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045395

Locations
Canada, Manitoba
Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Peter Jones Director Richardson Centre for Functional Foods and Nutraceuticals, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT01045395     History of Changes
Other Study ID Numbers: B2008:139
Study First Received: January 7, 2010
Last Updated: March 15, 2011
Health Authority: Canada: Health Canada
Canada: Natural Health Products Directorate

Keywords provided by University of Manitoba:
Algae
Psoriasis
Lipid metabolism
Inflammation
Oxidative stress

Additional relevant MeSH terms:
Inflammation
Psoriasis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014