Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT06215534
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glin3: Assessment of the Glycemic Responses to Nutritional Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärms"in total'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The glycemic index of nutritional products', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references', 'timeFrame': '6 months'}, {'measure': '2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycemic response', 'Glycemic Index', 'Nutritional products', 'Healthy individuals'], 'conditions': ['Glycemic Response']}, 'descriptionModule': {'briefSummary': 'This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 65 years\n* Body mass index (BMI) between 18.5 and 27 kg/m²\n\nExclusion Criteria:\n\n* Baseline fasting Glucose ≥6.1 at screening visit\n* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.\n* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.\n* Major trauma or surgical event within 3 months of screening.\n* Known intolerance, sensitivity or allergy to test products.\n* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).\n* History of cancer in the prior two years, except for non-melanoma skin cancer.'}, 'identificationModule': {'nctId': 'NCT06215534', 'acronym': 'GLIN#3', 'briefTitle': 'Glin3: Assessment of the Glycemic Responses to Nutritional Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals', 'orgStudyIdInfo': {'id': '23REX0060928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'arm 1', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: first reference product series 1']}, {'type': 'OTHER', 'label': 'arm 2', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: second reference product seies 1']}, {'type': 'OTHER', 'label': 'arm 3', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: third reference product series 1']}, {'type': 'OTHER', 'label': 'arm 4', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: first concept product series 1']}, {'type': 'OTHER', 'label': 'arm 5', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: second concept product series 1']}, {'type': 'OTHER', 'label': 'arm 6', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: third concept product series 1']}, {'type': 'OTHER', 'label': 'arm 7', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 4th concept product seris 1']}, {'type': 'OTHER', 'label': 'arm 8', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 5th concept product series 1']}, {'type': 'OTHER', 'label': 'arm 9', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 6th concept product series 1']}, {'type': 'OTHER', 'label': 'arm 10', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 1st reference product series 2']}, {'type': 'OTHER', 'label': 'arm 11', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 2nd reference product series 2']}, {'type': 'OTHER', 'label': 'arm 12', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 3rd reference product series 2']}, {'type': 'OTHER', 'label': 'arm 13', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 1st concept product series 2']}, {'type': 'OTHER', 'label': 'arm 14', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 2nd concept product series 2']}, {'type': 'OTHER', 'label': 'arm 15', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 3rd concept product series 2']}, {'type': 'OTHER', 'label': 'arm 16', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 4th concept product series 2']}, {'type': 'OTHER', 'label': 'arm 17', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 5th concept product series 2']}, {'type': 'OTHER', 'label': 'arm 18', 'description': 'All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.', 'interventionNames': ['Dietary Supplement: 6th concept product series 2']}], 'interventions': [{'name': 'first reference product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 1']}, {'name': 'second reference product seies 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 2']}, {'name': 'third reference product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 3']}, {'name': 'first concept product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard tube feed (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 4']}, {'name': 'second concept product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tube feed with added fibers (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 5']}, {'name': 'third concept product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tube feed with extra energy (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 6']}, {'name': '4th concept product seris 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 7']}, {'name': '5th concept product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates', 'armGroupLabels': ['arm 8']}, {'name': '6th concept product series 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates', 'armGroupLabels': ['arm 9']}, {'name': '1st reference product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 10']}, {'name': '2nd reference product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 11']}, {'name': '3rd reference product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dextrose (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 12']}, {'name': '1st concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High energy plant based tube feed (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 13']}, {'name': '2nd concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 14']}, {'name': '3rd concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High protein tube feed (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 15']}, {'name': '4th concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 16']}, {'name': '5th concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 17']}, {'name': '6th concept product series 2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)', 'armGroupLabels': ['arm 18']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2N8', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Inquis Clinical research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}