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CompletedNCT01045395PCAUpdated Mar 16, 2011

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

A Phase 1 interventional study of Corn starch and Unique Marine Algae Concentrate (UMAC) in Psoriasis, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-16.

Sponsored by University of Manitoba · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

Keywords

  • Algae
  • Psoriasis
  • Lipid metabolism
  • Inflammation
  • Oxidative stress
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    Corn starch, 90mg/d

    Corn starch, 90mg/d

    Dietary Supplement: Corn starch

  • Experimental
    Unique Marine Algae Concentrate (UMAC). 90mg/d

    Dietary Supplement: Unique Marine Algae Concentrate (UMAC)

  • Experimental
    Golden brown algae, 90mg/d

    Dietary Supplement: Golden brown algae

Interventions

  • Dietary supplementCorn starch

    90mg/d

  • Dietary supplementUnique Marine Algae Concentrate (UMAC)

    90mg/d

  • Dietary supplementGolden brown algae

    90mg/d

06

What researchers measure

Primary outcomes

  1. 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

  2. Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.

    Time frame: at the beginning and the end of each phase

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
    Winnipeg, Manitoba, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01045395
Lead sponsor
University of Manitoba
First posted
Jan 11, 2010
Start date
Sep 2009
Primary completion
Jun 2010
Completion
Nov 2010
Last update
Mar 16, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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