Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT01681069
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2012-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of IQP-VV-102 in Weight Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cj@a-r.com', 'phone': '+49 30 40 00 83 23', 'title': 'Dr Christof Jänicke', 'organization': 'Analyze & Realize GmBH'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'All adverse effect reported were not deemed associated with the investigational product', 'eventGroups': [{'id': 'EG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102', 'otherNumAtRisk': 57, 'otherNumAffected': 5, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo', 'otherNumAtRisk': 60, 'otherNumAffected': 8, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomitting and diarhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyrodism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruised left thigh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Weight at End of Study Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in body weight at the end of study compared to baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference (in cm) at End of Study From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '2.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Difference in waist circumference (in cm) at end of study from baseline', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Body Fat at End of Study From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Measured in kg using calibrated weighing scales', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Valid Case Analysis Set (VAS)', 'groupId': 'FG000', 'numSubjects': '55'}, {'comment': 'Valid Case Analysis Set (VAS)', 'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IQP-VV-102', 'description': '2 tablets twice a day\n\nIQP-VV-102'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 tablets twice a day\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '84.9', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '83.5', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '\\*Only 117 out of 118 subjects included in the intention-to-treat population as one subject was lost to follow-up after visit 3'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2012-09-04', 'resultsFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-05', 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight at End of Study Compared to Baseline', 'timeFrame': '12 weeks', 'description': 'Change in body weight at the end of study compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Waist Circumference (in cm) at End of Study From Baseline', 'timeFrame': '12 weeks', 'description': 'Difference in waist circumference (in cm) at end of study from baseline'}, {'measure': 'Change in Mean Body Fat at End of Study From Baseline', 'timeFrame': '12 weeks', 'description': 'Measured in kg using calibrated weighing scales'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '26074990', 'type': 'DERIVED', 'citation': 'Grube B, Bongartz U, Alt F. IQP-VV-102, a Novel Proprietary Composition for Weight Reduction: A Double-Blind Randomized Clinical Trial for Evaluation of Efficacy and Safety. Evid Based Complement Alternat Med. 2015;2015:413075. doi: 10.1155/2015/413075. Epub 2015 May 17.'}]}, 'descriptionModule': {'briefSummary': "Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 60 years\n* 25 kg/m2 ≤ BMI ≤ 35 kg/m2\n* Written informed consent\n\nExclusion Criteria:\n\n* Known sensitivity to sources of the active ingredients and excipients\n* Pregnancy or nursing\n* Inability to comply with study requirements, e.g. due to language difficulties\n* Participation in another study during the last 30 days of the screening visit'}, 'identificationModule': {'nctId': 'NCT01681069', 'briefTitle': 'Efficacy and Safety of IQP-VV-102 in Weight Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': 'INQ/009712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IQP-VV-102', 'description': '2 tablets twice a day', 'interventionNames': ['Dietary Supplement: IQP-VV-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 tablets twice a day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'IQP-VV-102', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['IQP-VV-102']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10709', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Barbara Grube', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Barbara Grube, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Practice for General Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}