Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-01-04 @ 1:18 AM
Study NCT ID:
NCT01568827
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inflammation, Polyphenols, and Genetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'joseph.kitzmiller@osumc.edu', 'phone': '6142928438', 'title': 'Dr. Joseph Kitzmiller', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Black-raspberry Slurry, Washout, Water', 'description': 'Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Water, Washout, Black-raspberry Slurry', 'description': 'Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Water', 'description': 'Water without lypholized black raspberry powder'}, {'id': 'OG001', 'title': 'Blackraspberry Slurry', 'description': 'Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '60.3'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '24.5', 'upperLimit': '41.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'acute (0-12 hours) after inflammation-causing challenge meal', 'description': 'Area Under the time-concentration Curve (AUC) of IL-6', 'unitOfMeasure': '(pg*hr)/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Water First, Then Washout, Then Blackraspberry Slurry', 'description': '8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days'}, {'id': 'FG001', 'title': 'Blackraspberry Slurry First, Then Washout, Then Water', 'description': 'Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days'}], 'periods': [{'title': 'First Intervention (6 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Intervention 2 (5 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Black-raspberry Powder', 'description': 'Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries'}, {'id': 'BG001', 'title': 'No Intervention', 'description': 'Water without lypholized black raspberry powder'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'older obese and overweight males'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2012-03-29', 'resultsFirstSubmitDate': '2015-09-25', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-17', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum IL-6', 'timeFrame': 'acute (0-12 hours) after inflammation-causing challenge meal', 'description': 'Area Under the time-concentration Curve (AUC) of IL-6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obese']}, 'referencesModule': {'references': [{'pmid': '23982695', 'type': 'RESULT', 'citation': 'Sardo CL, Kitzmiller JP, Apseloff G, Harris RB, Roe DJ, Stoner GD, Jacobs ET. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. Am J Ther. 2016 Jan-Feb;23(1):e86-91. doi: 10.1097/MJT.0b013e3182a40bf8.'}]}, 'descriptionModule': {'briefSummary': "Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.", 'detailedDescription': 'A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult males over 55 years of age\n* overweight or obese\n\nExclusion Criteria:\n\n* history of adverse reaction to berries or berry products\n* history of adverse reaction to high-fat, high-calorie challenge meal\n* significant liver or renal insufficiency\n* significant cognitive impairment'}, 'identificationModule': {'nctId': 'NCT01568827', 'briefTitle': 'Inflammation, Polyphenols, and Genetics', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal', 'orgStudyIdInfo': {'id': 'OSU 2011H0394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blackraspberry slurry, washout, water', 'description': 'Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days', 'interventionNames': ['Dietary Supplement: Blackraspberry Slurry']}, {'type': 'EXPERIMENTAL', 'label': 'Water, washout, Blackraspberry slurry', 'description': '8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days', 'interventionNames': ['Dietary Supplement: Blackraspberry Slurry']}], 'interventions': [{'name': 'Blackraspberry Slurry', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.', 'armGroupLabels': ['Blackraspberry slurry, washout, water', 'Water, washout, Blackraspberry slurry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univesity', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joseph P Kitzmiller, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joseph Kitzmiller', 'investigatorAffiliation': 'Ohio State University'}}}}