Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT00489333
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-19', 'studyFirstSubmitDate': '2007-06-19', 'studyFirstSubmitQcDate': '2007-06-19', 'lastUpdatePostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hsCRP', 'timeFrame': '10 weeks'}, {'measure': 'Lipids (total cholesterol, triglycerides HDL-C, LDL-C)', 'timeFrame': '10 weeks'}, {'measure': 'Anthropometric measurements (weight/BMI, % body fat, blood pressure)', 'timeFrame': '10 weeks'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin', 'timeFrame': '10 weeks'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': '10 weeks'}, {'measure': 'TNF-alpha', 'timeFrame': '10 weeks'}, {'measure': 'RBC Sedimentation Rate', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ProAlgaZyme', 'Metabolic syndrome', 'Inflammation', 'Cardiovascular', 'hsCRP', 'Lipids', 'Algae'], 'conditions': ['Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '17803818', 'type': 'DERIVED', 'citation': 'Oben J, Enonchong E, Kuate D, Mbanya D, Thomas TC, Hildreth DJ, Ingolia TD, Tempesta MS. The effects of ProAlgaZyme novel algae infusion on metabolic syndrome and markers of cardiovascular health. Lipids Health Dis. 2007 Sep 5;6:20. doi: 10.1186/1476-511X-6-20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.', 'detailedDescription': 'Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements.\n\nComparisons: ProAlgaZyme vs. placebo \\[Time frame: 10 weeks\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must meet 3 of the following criteria:\n\n * BMI ≥30 kg/m2\n * HDL Cholesterol of \\<40\n * Triglycerides \\>150 mg/dl\n * Fasting blood glucose \\>100 mg/dl\n * Blood pressure \\>130/85 mm Hg\n * Total Cholesterol of \\>200 mg/dl\n * LDL Cholesterol of \\>160 mg/dl\n * Interleukin 6 (IL-6) \\>5pg/mL\n\nExclusion Criteria:\n\n* Morbidly obese: BMI \\>40 kg/m2\n* Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.\n* Enrolled in another clinical study in the past 6 months.\n* Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.'}, 'identificationModule': {'nctId': 'NCT00489333', 'briefTitle': 'ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Health Enhancement Products, Inc.'}, 'officialTitle': 'The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health', 'orgStudyIdInfo': {'id': 'H-0001-01'}, 'secondaryIdInfos': [{'id': '087/2006'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ProAlgaZyme', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yaoundé', 'country': 'Cameroon', 'facility': 'Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}], 'overallOfficials': [{'name': 'Julius Oben, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory of Nutrition and Nutritional Biochemistry (LNNB), Department of Biochemistry, University of Yaounde I, Yaounde, Cameroon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Health Enhancement Products, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Yaounde', 'class': 'OTHER'}]}}}