Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:03 PM
Study NCT ID:
NCT05291806
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2022-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting GLP-1', 'timeFrame': 'Outcome measures will be assessed just before the standardized meal is consumed.', 'description': 'The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.'}, {'measure': 'GLP-1 iAUC(0-120 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.'}, {'measure': 'GLP-1 iAUC(0-60 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.'}, {'measure': 'GLP-1 Cmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.'}, {'measure': 'GLP-1 Tmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.'}, {'measure': 'Fasting PYY', 'timeFrame': 'Outcome measures will be assessed just before the standardized meal is consumed.', 'description': 'The change in fasting PYY the morning after consuming either wholegrain products or reference.'}, {'measure': 'PYY 2-hour mean concentration', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.'}, {'measure': 'PYY 1-hour mean concentration', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.'}], 'primaryOutcomes': [{'measure': 'Postprandial capillary blood glucose iAUC (0-120 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.'}], 'secondaryOutcomes': [{'measure': 'Postprandial capillary blood glucose Cmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.'}, {'measure': 'Postprandial capillary blood glucose Tmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.'}, {'measure': 'Fasting capillary blood glucose', 'timeFrame': 'Outcome measures will be assessed just before the standardized meal is consumed.', 'description': 'The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.'}, {'measure': 'Postprandial capillary blood glucose iAUC (0-60 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.'}, {'measure': 'Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.'}, {'measure': 'Postprandial Insulin iAUC(0-120 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.'}, {'measure': 'Postprandial Insulin Cmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.'}, {'measure': 'Postprandial Insulin Tmax', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.'}, {'measure': 'Fasting Insulin', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.'}, {'measure': 'Postprandial insulin iAUC (0-60 min)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.'}, {'measure': 'Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)', 'timeFrame': 'Outcome measures will be assessed just before and immediately after the standardized meal is consumed.', 'description': 'The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Glucose Response']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or Female, 35 to 65 years of age\n2. BMI 18.5-29.9 kg/m2\n3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.\n4. Healthy as determined by medical history and information provided by the volunteer.\n5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.\n6. Has given voluntary, written, informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)\n2. Women who are pregnant or breast feeding\n3. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI\n4. Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.\n5. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.\n6. Use of antibiotics within 2 weeks of enrollment\n7. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)\n8. Allergy to ingredients included in investigational product, reference, or standardized meal\n9. Participants restricted to a vegetarian or vegan diet\n10. Intolerance to gluten\n11. Individuals who are averse to venous catheterization or capillary blood sampling\n12. Currently active smokers (or using other tobacco products, and e-cigarettes)\n13. Unstable medical conditions as determined by QI\n14. Participation in other clinical research trials\n15. Individuals who are cognitively impaired and/or who are unable to give informed consent\n16. Acute infection\n17. Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual\n\n \\-"}, 'identificationModule': {'nctId': 'NCT05291806', 'briefTitle': 'Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aventure AB'}, 'officialTitle': 'Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response', 'orgStudyIdInfo': {'id': 'TSP2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Reference', 'interventionNames': ['Other: Reference Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole cereal kernels Dose A', 'interventionNames': ['Other: Wholegrain product Dose A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole cereal kernels Dose B', 'interventionNames': ['Other: Wholegrain product Dose B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cut cereal kernels Dose A', 'interventionNames': ['Other: Wholegrain product Dose A, cut kernels']}], 'interventions': [{'name': 'Reference Product', 'type': 'OTHER', 'description': 'This intervention is based on white rice.', 'armGroupLabels': ['Reference']}, {'name': 'Wholegrain product Dose A', 'type': 'OTHER', 'description': 'This wholegrain intervention contains whole cereal kernels.', 'armGroupLabels': ['Whole cereal kernels Dose A']}, {'name': 'Wholegrain product Dose B', 'type': 'OTHER', 'description': 'This wholegrain intervention contains whole cereal kernels.', 'armGroupLabels': ['Whole cereal kernels Dose B']}, {'name': 'Wholegrain product Dose A, cut kernels', 'type': 'OTHER', 'description': 'This wholegrain intervention contains cut cereal kernels.', 'armGroupLabels': ['Cut cereal kernels Dose A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Aventure AB', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aventure AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}