Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT00457756
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2007-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of BiosLife on Serum Lipids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-05', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-05', 'lastUpdatePostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL cholesterol', 'timeFrame': '12 weeks'}, {'measure': 'HDL cholesterol', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'triglycerides', 'timeFrame': '12 weeks'}, {'measure': 'LDL particle number', 'timeFrame': '12 weeks'}, {'measure': 'LDL particle size distribution', 'timeFrame': '12 weeks'}, {'measure': 'HDL particle number', 'timeFrame': '12 weeks'}, {'measure': 'HDL particle size distribution', 'timeFrame': '12 weeks'}, {'measure': 'VLDL particle number', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LDL cholesterol', 'HDL cholesterol', 'natural supplement', 'guar gum', 'phytosterols', 'policosanol', 'chrysanthemum'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100 subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks and 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* LDL-C 110 - 190 mg/dL\n* For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.\n* Age 18 - 85 years\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Severe hypertension, defined as at least 180 / 100 mmHg\n* Any other health condition that may interfere with the study results, as judged by the principle investigator\n* Allergy against any of the ingredients in the tested product\n* Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's disease\n* The use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement.\n* History of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study\n* Pregnant or breast feeding\n* Persons who eat only 1 meal per day"}, 'identificationModule': {'nctId': 'NCT00457756', 'briefTitle': 'The Effect of BiosLife on Serum Lipids', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'BiosLife 2005-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Cohort I subjects will take supplement for 12 weeks', 'interventionNames': ['Dietary Supplement: BiosLife Complete']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'II', 'description': 'Cohort II will take placebo for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'BiosLife Complete', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['I']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Cardiovascular Genetics, University of Utah, 420 Chipeta Way, Room 1160', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Paul N Hopkins, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unicity International', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Paul Hopkins, MD, MSPH', 'oldOrganization': 'University of Utah'}}}}