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

NCT01045395 | Completed Phase 1 DMC

• 1 other identifier: B2008:139
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Algae; Psoriasis; Lipid metabolism; Inflammation; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• 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.

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

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

  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.

  at the beginning and the end of each phase

Study Arms (3)

Corn starch, 90mg/d

PLACEBO COMPARATOR

Corn starch, 90mg/d

Dietary Supplement: Corn starch

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

EXPERIMENTAL

Dietary Supplement: Unique Marine Algae Concentrate (UMAC)

Golden brown algae, 90mg/d

EXPERIMENTAL

Dietary Supplement: Golden brown algae

Interventions

Corn starch DIETARY_SUPPLEMENT

90mg/d

Corn starch, 90mg/d

Unique Marine Algae Concentrate (UMAC) DIETARY_SUPPLEMENT

90mg/d

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

Golden brown algae DIETARY_SUPPLEMENT

90mg/d

Golden brown algae, 90mg/d

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Psoriasis; Inflammation

Interventions

Starch

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 16, 2011

Record last verified: 2010-01

Locations

CA (1)