Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-31 @ 4:34 PM
Study NCT ID:
NCT01045395
Status:
COMPLETED
Last Update Posted:
2011-03-16
First Post:
2010-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-15', 'studyFirstSubmitDate': '2010-01-07', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'at the beginning and end of each of the three intervention periods'}, {'measure': 'Total cholesterol, LDL- cholesterol, HDL-cholesterol and Triglycerides in plasma, will be determined.', 'timeFrame': 'at the beginning and the end of each phase'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'at the beginning and the end of each phase'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Algae', 'Psoriasis', 'Lipid metabolism', 'Inflammation', 'Oxidative stress'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with clinically diagnosed psoriasis\n* Plasma LDL-C 80-190 mg/dL, and TG levels below 400 mg/dL.\n* Body mass index (BMI) range will be 22 to 32 kg/m2.\n* Subjects must demonstrate an ability to understand dietary procedures and be judged as compliant and motivated by the investigators.\n* 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.\n* potential subjects must have stable psoriasis and their treatments must remain constant throughout the study.\n\nExclusion Criteria:\n\n* recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 mo\n* history of chronic use of alcohol (\\>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin\n* 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\n* myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months\n* 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\n* moderate or high risk for CAD\n* uncontrolled hypertension defined as untreated systolic blood pressure \\> 160 mmHg and/or diastolic blood pressure \\> 100 mmHg\n* pregnant, breastfeeding, or planning to become pregnant during the course of the trial\n* bleeding disorder, anemia, or significant recent blood loss/donation\n* allergy/sensitivity to any of the ingredients in the study product or placebo\n* 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.'}, 'identificationModule': {'nctId': 'NCT01045395', 'acronym': 'PCA', 'briefTitle': 'Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Efficacy of Two Algae Formulations on Lipid Metabolism, Inflammation and Oxidative Stress Status in Individuals With Psoriasis', 'orgStudyIdInfo': {'id': 'B2008:139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Corn starch, 90mg/d', 'description': 'Corn starch, 90mg/d', 'interventionNames': ['Dietary Supplement: Corn starch']}, {'type': 'EXPERIMENTAL', 'label': 'Unique Marine Algae Concentrate (UMAC). 90mg/d', 'interventionNames': ['Dietary Supplement: Unique Marine Algae Concentrate (UMAC)']}, {'type': 'EXPERIMENTAL', 'label': 'Golden brown algae, 90mg/d', 'interventionNames': ['Dietary Supplement: Golden brown algae']}], 'interventions': [{'name': 'Corn starch', 'type': 'DIETARY_SUPPLEMENT', 'description': '90mg/d', 'armGroupLabels': ['Corn starch, 90mg/d']}, {'name': 'Unique Marine Algae Concentrate (UMAC)', 'type': 'DIETARY_SUPPLEMENT', 'description': '90mg/d', 'armGroupLabels': ['Unique Marine Algae Concentrate (UMAC). 90mg/d']}, {'name': 'Golden brown algae', 'type': 'DIETARY_SUPPLEMENT', 'description': '90mg/d', 'armGroupLabels': ['Golden brown algae, 90mg/d']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Ricahrson Centre for Functionl Foods and Nutraceuticals, U of M', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Peter Jones Director Richardson Centre for Functional Foods and Nutraceuticals', 'oldOrganization': 'Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba'}}}}