Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-07 @ 3:31 PM
Study NCT ID:
NCT01409668
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2011-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Two Yogurt Formulations in Healthy Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol Metabolism', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as gastrointestinal microflora distribution in hyperlipidemic individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females\n* aged 18-60 yr\n* plasma LDL-C 130-260 mg/dl\n* TG levels below 400 mg/dl\n* body mass index (BMI) rangewill be 22 to 32 kg/m2\n* permitted to take stable doses of thyroid hormone and anti hypertensive agents, as long as these are continued equivalently throughout the duration of study\n\nExclusion Criteria:\n\n* history of 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,\n* myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months\n* recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, lactose intolerance or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year\n* chronic user of probiotics, 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': 'NCT01409668', 'acronym': 'MPH', 'briefTitle': 'Efficacy of Two Yogurt Formulations in Healthy Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Efficacy of Two Yogurt Formulations as Health Promoting Agents in Healthy Humans', 'orgStudyIdInfo': {'id': 'B2007:070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L. Amylovorus', 'interventionNames': ['Dietary Supplement: L. Amylovorus']}, {'type': 'EXPERIMENTAL', 'label': 'L. Fermentum', 'interventionNames': ['Dietary Supplement: L. Fermentum']}], 'interventions': [{'name': 'L. Amylovorus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'L. Amylovorus', 'armGroupLabels': ['L. Amylovorus']}, {'name': 'L. Fermentum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'L. Fermentum', 'armGroupLabels': ['L. Fermentum']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Micropharma Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Peter Jones, Director of RCFFN', 'oldOrganization': 'RCFFN, University of Manitoba'}}}}