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

U

University of Manitoba

Status and phase

Completed
Phase 1

Conditions

Psoriasis

Treatments

Dietary Supplement: Corn starch
Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
Dietary Supplement: Golden brown algae

Study type

Interventional

Funder types

Other

Identifiers

NCT01045395
B2008:139

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups, including a placebo group

Corn starch, 90mg/d
Placebo Comparator group
Description:
Corn starch, 90mg/d
Treatment:
Dietary Supplement: Corn starch
Unique Marine Algae Concentrate (UMAC). 90mg/d
Experimental group
Treatment:
Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
Golden brown algae, 90mg/d
Experimental group
Treatment:
Dietary Supplement: Golden brown algae

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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