Trial record 5 of 5 for:
TNFRSF1B
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis (PCA)
This study has been completed.
Sponsor:
University of Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01045395
First received: January 7, 2010
Last updated: March 15, 2011
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Dietary Supplement: Corn starch Dietary Supplement: Unique Marine Algae Concentrate (UMAC) Dietary Supplement: Golden brown algae |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis |
Resource links provided by NLM:
Further study details as provided by University of Manitoba:
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. [ Time Frame: at the beginning and end of each of the three intervention periods ] [ Designated as safety issue: No ]
- Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
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. [ Time Frame: at the beginning and the end of each phase ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Corn starch, 90mg/d
Corn starch, 90mg/d
|
Dietary Supplement: Corn starch
90mg/d
|
| Experimental: Unique Marine Algae Concentrate (UMAC). 90mg/d |
Dietary Supplement: Unique Marine Algae Concentrate (UMAC)
90mg/d
|
| Experimental: Golden brown algae, 90mg/d |
Dietary Supplement: Golden brown algae
90mg/d
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Dr. Peter Jones Director Richardson Centre for Functional Foods and Nutraceuticals, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01045395 History of Changes |
| Other Study ID Numbers: | B2008:139 |
| Study First Received: | January 7, 2010 |
| Last Updated: | March 15, 2011 |
| Health Authority: | Canada: Health Canada Canada: Natural Health Products Directorate |
Keywords provided by University of Manitoba:
|
Algae Psoriasis Lipid metabolism Inflammation Oxidative stress |
Additional relevant MeSH terms:
|
Inflammation Psoriasis Pathologic Processes Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013