Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT04273659
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011674', 'term': 'Pulse'}, {'id': 'D002523', 'term': 'Edible Grain'}], 'ancestors': [{'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D018556', 'term': 'Crops, Agricultural'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012639', 'term': 'Seeds'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, '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': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath gases', 'timeFrame': 'Day 4', 'description': 'Breath hydrogen and methane are measured by Gastrocheck device.'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal symptoms (self-reported)', 'timeFrame': 'Day 1-4', 'description': 'Gastrointestinal symptoms as measured as questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unidentified Gastrointestinal Symptoms Following Pulses Consumption']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.', 'detailedDescription': 'The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects with subjective experience of gut symptoms after consumption of pulses\n* Celiac disease and wheat allergy excluded by antigen test\n* Age 18-65\n* BMI 18,5 - 30\n* Normal liver, thyroid and kidney functions\n\nExclusion Criteria:\n\n* Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis\n* Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)\n* Antibiotic treatment within previous 3 months\n* Blood donation or participation to another clinical trial within one month prior to study entry"}, 'identificationModule': {'nctId': 'NCT04273659', 'briefTitle': 'Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?', 'orgStudyIdInfo': {'id': 'Pulses'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulses and Cereal 1', 'description': 'Pulses and cereal 1 containing study product is served. Dietary intervention.', 'interventionNames': ['Dietary Supplement: Pulses and cereals']}, {'type': 'EXPERIMENTAL', 'label': 'Pulses and Cereal 2', 'description': 'Pulses and cereal 2 containing study product is served. Dietary intervention.', 'interventionNames': ['Dietary Supplement: Pulses and cereals']}], 'interventions': [{'name': 'Pulses and cereals', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.', 'armGroupLabels': ['Pulses and Cereal 1', 'Pulses and Cereal 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20014', 'city': 'Turku', 'country': 'Finland', 'facility': 'Department of Biochemistry, University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Kaisa Linderborg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biochemistry, University of Turku'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Molecular Food Sciences (acting)', 'investigatorFullName': 'Kaisa Linderborg', 'investigatorAffiliation': 'University of Turku'}}}}