Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 2:57 PM
Study NCT ID:
NCT01989702
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Probiotic-based Product on Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-14', 'studyFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of study product on intestinal microbiota as analysed in fecal samples', 'timeFrame': 'Baseline, 3 months'}], 'primaryOutcomes': [{'measure': 'Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention', 'timeFrame': 'Baseline, 3 months'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases', 'timeFrame': 'Baseline, 3 months'}]}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals at the age of 40-75 years.\n* Blood-pressure \\>140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.\n* Triglycerides \\>1,7 mmol/L and/or HDL \\<1 mmol/L (men)/1,29 mmol/L (women).\n* Fasting plasma glucose levels \\>5,6 mmol/L and/or waist circumference \\>102 cm (men)/88 cm (women).\n* BMI \\<40.\n\nExclusion Criteria:\n\n* Medically treated allergy or allergy to any of the ingredients of the study product.\n* Medication for high levels of blood lipids.\n* Metabolic disease, such as type one diabetes.\n* Confirmed diseases of the heart, liver of kidneys.\n* Chronic inflammatory disease requiring medication.\n* Pregnant or nursing.\n* Regular intake of other probiotic products (5-7 days per week during the last three months before inclusion into the study).'}, 'identificationModule': {'nctId': 'NCT01989702', 'briefTitle': 'Effect of a Probiotic-based Product on Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'officialTitle': 'The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.', 'orgStudyIdInfo': {'id': 'ProMeta'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fermented blueberry product', 'interventionNames': ['Other: Fermented blueberry drink', 'Other: Sachets with placebo powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo drink', 'Other: Sachets with placebo powder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic bacteria', 'interventionNames': ['Other: Placebo drink', 'Other: Sachets with probiotic bacterial powder']}], 'interventions': [{'name': 'Fermented blueberry drink', 'type': 'OTHER', 'armGroupLabels': ['Fermented blueberry product']}, {'name': 'Placebo drink', 'type': 'OTHER', 'armGroupLabels': ['Placebo', 'Probiotic bacteria']}, {'name': 'Sachets with probiotic bacterial powder', 'type': 'OTHER', 'armGroupLabels': ['Probiotic bacteria']}, {'name': 'Sachets with placebo powder', 'type': 'OTHER', 'armGroupLabels': ['Fermented blueberry product', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}