Trial record 6 of 6 for:    TNFRSF1B

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
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 April 16, 2014