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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Corn starch
Unique Marine Algae Concentrate (UMAC)
Golden brown algae
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Corn starch, 90mg/d

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

Golden brown algae, 90mg/d

Arm Description

Corn starch, 90mg/d

Outcomes

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

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.

Full Information

First Posted
January 7, 2010
Last Updated
March 15, 2011
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01045395
Brief Title
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Acronym
PCA
Official Title
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Algae, Psoriasis, Lipid metabolism, Inflammation, Oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corn starch, 90mg/d
Arm Type
Placebo Comparator
Arm Description
Corn starch, 90mg/d
Arm Title
Unique Marine Algae Concentrate (UMAC). 90mg/d
Arm Type
Experimental
Arm Title
Golden brown algae, 90mg/d
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn starch
Intervention Description
90mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Unique Marine Algae Concentrate (UMAC)
Intervention Description
90mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Golden brown algae
Intervention Description
90mg/d
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M
City
Winnipeg
State/Province
Manitoba
Country
Canada

12. IPD Sharing Statement

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

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