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

Phase 1
18 Years
60 Years
Not Enrolling

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

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.

Outcome Time Frame:

at the beginning and end of each of the three intervention periods

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

September 2009

Completion Date:

November 2010

Related Keywords:

  • Psoriasis
  • Algae
  • Psoriasis
  • Lipid metabolism
  • Inflammation
  • Oxidative stress
  • Inflammation
  • Psoriasis