Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-26 @ 9:57 PM
Study NCT ID:
NCT01287403
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2011-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Response of Alkylresorcinols to Different Cereals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maurice.beaumont@rdls.nestle.com', 'phone': '+41217858054', 'title': 'Dr Maurice Beaumont, MD, PhD', 'organization': 'Clinical Development Unit / Metabolic Unit'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This adverse event occurred during the 1st intervention. The subject did not wish to go on with the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Refined Wheat Flour', 'description': 'A treated cereal flour mixed with milk (negative control).', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Esterase Wholegrain Wheat Flour', 'description': 'A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Liquid Whole Grain Wheat Flour', 'description': 'A treated cereal flour mixed with milk.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Liquid Wholegrain Barley Flour', 'description': 'A treated cereal flour mixed with milk.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Wholegrain Wheat Flour', 'description': 'A treated cereal flour mixed with milk.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Wholegrain Barley Flour', 'description': 'A treated cereal flour mixed with milk.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'notes': 'The subject complain of nausea in the hour following the product intake and vomitted 8 hours later.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Vomiting'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Alkylresorcinol Compounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Esterase Whole Grain Wheat Flour', 'description': 'A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).'}, {'id': 'OG001', 'title': 'Refined Wheat Flour', 'description': 'A treated cereal flour mixed with milk(negative control).'}, {'id': 'OG002', 'title': 'Liquid Whole Grain Wheat Flour', 'description': 'A treated cereal flour mixed with milk.'}, {'id': 'OG003', 'title': 'Liquid Wholegrain Barley Flour', 'description': 'A treated cereal flour mixed with milk.'}, {'id': 'OG004', 'title': 'Wholegrain Wheat Flour', 'description': 'A treated cereal flour mixed with milk.'}, {'id': 'OG005', 'title': 'Wholegrain Barley Flour', 'description': 'A treated cereal flour mixed with milk.'}], 'classes': [{'categories': [{'measurements': [{'value': '19357', 'spread': '7509', 'groupId': 'OG000'}, {'value': '1548', 'spread': '698', 'groupId': 'OG001'}, {'value': '17307', 'spread': '5914', 'groupId': 'OG002'}, {'value': '5385', 'spread': '2642', 'groupId': 'OG003'}, {'value': '17139', 'spread': '6386', 'groupId': 'OG004'}, {'value': '5634', 'spread': '2478', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 0 to 48 h post dose.', 'description': 'Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.', 'unitOfMeasure': 'nmol/L*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma and Urinary Betaine', 'timeFrame': 'From 0 to 48 hours post dose', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phenolic Acids', 'timeFrame': '0-48 h post dose', 'description': 'Phenolic acids in plasma and urine', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Six Products (Flours) Assigned Randomly (Cross Over)', 'description': 'In a crossover design, all subjects were administered the 6 following products in a randomized order:\n\nEsterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).\n\nRefined wheat flour: a treated cereal flour mixed with milk (negative control).\n\nLiquid whole grain wheat flour: a treated cereal flour mixed with milk.\n\nLiquid wholegrain barley flour: a treated cereal flour mixed with milk.\n\nWholegrain wheat flour: a treated cereal flour mixed with milk.\n\nWholegrain barley flour: a treated cereal flour mixed with milk.'}], 'periods': [{'title': 'Diet Restriction (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '1st Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The adverse event was linked to the intake of "refined wheat flour"', 'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '2nd Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '3rd Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '4th Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '5th Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '6th and Last Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '14 healthy subjects were recruited within the staff of the Nestle Research Center. After being informed, by written and orally, on the aims, methods, risk/benefit ratio for the study, they signed an informed consent form and underwent a medical visit screening as per protocol', 'preAssignmentDetails': 'Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.\n\nSubjects avoided foods containing whole grains for one week prior, and 36 h before the start of each treatment, to avoid all phenolic-rich foods (e.g. coffee, tea, chocolate, most fruits and vegetables).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'between 18 and 55 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '> 55 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects were recruited within the staff of the Nestlé Research Center between February and June 2011.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2011-01-30', 'resultsFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-11', 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Alkylresorcinol Compounds', 'timeFrame': 'From 0 to 48 h post dose.', 'description': 'Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.'}], 'secondaryOutcomes': [{'measure': 'Plasma and Urinary Betaine', 'timeFrame': 'From 0 to 48 hours post dose'}, {'measure': 'Phenolic Acids', 'timeFrame': '0-48 h post dose', 'description': 'Phenolic acids in plasma and urine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cereals', 'Alkylresorcinols', 'Betaine', 'Phenolics', 'Plasma and urine cereal phytochemicals'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Cereal grains contain a wide variety of different phytochemicals which may play different roles in physiology. Their response in plasma and urine after a meal is poorly defined for most cereals. This study will investigate the plasma response and urinary excretion of cereal compounds after eating 6 different types of cereal preparation, with a focus on alkylresorcinols.', 'detailedDescription': 'This was a cross-over, randomized, double blind study with 6 arms (flours of different composition). Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Normal-overweight (BMI 19-28 kg/m2)\n* Non-smokers\n\nExclusion Criteria:\n\n* Regular consumers of wholegrain cereals\n* Allergy to cereal or milk products'}, 'identificationModule': {'nctId': 'NCT01287403', 'briefTitle': 'Response of Alkylresorcinols to Different Cereals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Response of Alkylresorcinols and Other Biomarkers to Different Cereals', 'orgStudyIdInfo': {'id': '10.14 MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Refined wheat flour', 'description': 'A negative control flour to serve as a reference.', 'interventionNames': ['Other: Esterase wholegrain wheat flour', 'Other: Wholegrain wheat flour', 'Other: Liquid whole grain wheat flour', 'Other: Wholegrain barley flour', 'Other: Liquid wholegrain barley flour']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esterase wholegrain wheat flour', 'description': 'Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)', 'interventionNames': ['Other: Refined wheat flour', 'Other: Wholegrain wheat flour', 'Other: Liquid whole grain wheat flour', 'Other: Wholegrain barley flour', 'Other: Liquid wholegrain barley flour']}, {'type': 'EXPERIMENTAL', 'label': 'Wholegrain wheat flour', 'description': 'Flour with unknown response', 'interventionNames': ['Other: Refined wheat flour', 'Other: Esterase wholegrain wheat flour', 'Other: Liquid whole grain wheat flour', 'Other: Wholegrain barley flour', 'Other: Liquid wholegrain barley flour']}, {'type': 'EXPERIMENTAL', 'label': 'Liquid whole grain wheat flour', 'description': 'Test flour with unknown response.', 'interventionNames': ['Other: Refined wheat flour', 'Other: Esterase wholegrain wheat flour', 'Other: Wholegrain wheat flour', 'Other: Wholegrain barley flour', 'Other: Liquid wholegrain barley flour']}, {'type': 'EXPERIMENTAL', 'label': 'Wholegrain barley flour', 'description': 'Test flour with unknown response.', 'interventionNames': ['Other: Refined wheat flour', 'Other: Esterase wholegrain wheat flour', 'Other: Wholegrain wheat flour', 'Other: Liquid whole grain wheat flour', 'Other: Liquid wholegrain barley flour']}, {'type': 'EXPERIMENTAL', 'label': 'Liquid wholegrain barley flour', 'description': 'Test flour with unknown response.', 'interventionNames': ['Other: Refined wheat flour', 'Other: Esterase wholegrain wheat flour', 'Other: Wholegrain wheat flour', 'Other: Liquid whole grain wheat flour', 'Other: Wholegrain barley flour']}], 'interventions': [{'name': 'Refined wheat flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Esterase wholegrain wheat flour', 'Liquid whole grain wheat flour', 'Liquid wholegrain barley flour', 'Wholegrain barley flour', 'Wholegrain wheat flour']}, {'name': 'Esterase wholegrain wheat flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Liquid whole grain wheat flour', 'Liquid wholegrain barley flour', 'Refined wheat flour', 'Wholegrain barley flour', 'Wholegrain wheat flour']}, {'name': 'Wholegrain wheat flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Esterase wholegrain wheat flour', 'Liquid whole grain wheat flour', 'Liquid wholegrain barley flour', 'Refined wheat flour', 'Wholegrain barley flour']}, {'name': 'Liquid whole grain wheat flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Esterase wholegrain wheat flour', 'Liquid wholegrain barley flour', 'Refined wheat flour', 'Wholegrain barley flour', 'Wholegrain wheat flour']}, {'name': 'Wholegrain barley flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Esterase wholegrain wheat flour', 'Liquid whole grain wheat flour', 'Liquid wholegrain barley flour', 'Refined wheat flour', 'Wholegrain wheat flour']}, {'name': 'Liquid wholegrain barley flour', 'type': 'OTHER', 'description': 'A treated cereal flour mixed with milk.', 'armGroupLabels': ['Esterase wholegrain wheat flour', 'Liquid whole grain wheat flour', 'Refined wheat flour', 'Wholegrain barley flour', 'Wholegrain wheat flour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'NESTEC / Clinical Development Unit / Metabolic Unit', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Alastair B Ross, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'CDUuser', 'investigatorAffiliation': 'Société des Produits Nestlé (SPN)'}}}}