Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 7:11 AM
Study NCT ID:
NCT03190993
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The DEB Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'john.apolzan@pbrc.edu', 'phone': '225-763-2827', 'title': 'John Apolzan', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Sugar Sweetened Solid Treatment', 'description': 'A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.\n\nSugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Sweetened Beverage Treatment', 'description': '20 oz. carbonated sugar sweetened beverage. Added ingredients include: \\~2.1g whey protein powder.\n\nSugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugar Sweetened Solid Treatment', 'description': 'A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.\n\nSugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.'}, {'id': 'OG001', 'title': 'Sugar Sweetened Beverage Treatment', 'description': '20 oz. carbonated sugar sweetened beverage. Added ingredients include: \\~2.1g whey protein powder.\n\nSugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.325', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '0.230', 'spread': '0.307', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Change from baseline in body weight at 1 month', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugar Sweetened Solid Treatment', 'description': 'A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.\n\nSugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.'}, {'id': 'FG001', 'title': 'Sugar Sweetened Beverage Treatment', 'description': '20 oz. carbonated sugar sweetened beverage. Added ingredients include: \\~2.1g whey protein powder.\n\nSugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugar Sweetened Solid Treatment', 'description': 'A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.\n\nSugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.'}, {'id': 'BG001', 'title': 'Sugar Sweetened Beverage Treatment', 'description': '20 oz. carbonated sugar sweetened beverage. Added ingredients include: \\~2.1g whey protein powder.\n\nSugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '50'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '56'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '56'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', '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'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-03-08', 'size': 232778, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-08-26T14:51', 'hasProtocol': False}, {'date': '2018-03-08', 'size': 249912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-26T14:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2017-06-15', 'resultsFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': '1 month', 'description': 'Change from baseline in body weight at 1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutritional Physiological Phenomena', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.', 'detailedDescription': 'Dose: Participants are to consume 1 unit per day of the study product.\n\nDiet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 20 - 40\n\nExclusion Criteria:\n\n* Diabetes (Type 1 or 2)\n* Prediabetes\n* Active cancer\n* Serious digestive disorders\n* Other conditions that affect metabolism or body weight\n* Uncontrolled Thyroid disorder (controlled = 6 months of medication)\n* Unable to consume study foods\n* Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)\n* Pregnancy\n* Intentions of becoming pregnant in the next 2 months\n* Women who have undergone partial hysterectomy with intact ovary function\n* Current or past alcohol or drug abuse problem\n* Allergy or intolerance to study product ingredients.\n* Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol'}, 'identificationModule': {'nctId': 'NCT03190993', 'acronym': 'DEB Pilot', 'briefTitle': 'The DEB Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Diet Composition and Energy Balance Pilot Study', 'orgStudyIdInfo': {'id': '6218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sugar Sweetened Solid Treatment', 'description': 'A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.', 'interventionNames': ['Other: Sugar Sweetened Solid Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sugar Sweetened Beverage Treatment', 'description': '20 oz. carbonated sugar sweetened beverage. Added ingredients include: \\~2.1g whey protein powder.', 'interventionNames': ['Other: Sugar Sweetened Beverage Treatment']}], 'interventions': [{'name': 'Sugar Sweetened Solid Treatment', 'type': 'OTHER', 'description': 'Consume Sugar Sweetened Solid Treatment (product) daily.', 'armGroupLabels': ['Sugar Sweetened Solid Treatment']}, {'name': 'Sugar Sweetened Beverage Treatment', 'type': 'OTHER', 'otherNames': ['SSB Treatment'], 'description': 'Consume Sugar Sweetened Beverage Treatment (product) daily.', 'armGroupLabels': ['Sugar Sweetened Beverage Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Martin, Corby, K., M.D.', 'class': 'INDIV'}, {'name': 'Owen T. Carmichael', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'John Apolzan', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}