Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:46 AM
Study NCT ID:
NCT07479251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic Index (GI) of ONS', 'timeFrame': 'Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.', 'description': 'Three GIs for each repeated test of the ONS (based on capillary blood glucose) and their average GI (mean value) will be calculated as per ISO 26642.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates the postprandial glycaemic response to an Oral Nutritional Supplement (ONS), a Food for Special Medical Purposes (FSMP), in healthy adults. The study uses a crossover design comparing the ONS to the reference product glucose.\n\nEach participant will consume both test and reference products on three separate occasions each, overall on six test days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 and ≤60 years, adult healthy Caucasian or Chinese participants\n* Stable body weight within the Body Mass Index between 18.5 kg/m2 and 27.9 kg/m2 (inclusive)\n* Glycated hemoglobin \\< 6%/\\< 42 mmol/mol\n\nExclusion Criteria:\n\n* Pregnant or lactating,\n* Body fat percentage exceeding 30%,\n* Known history of metabolic diseases or diabetes mellitus,\n* Major medical or surgical event requiring hospitalization within the preceding 3 months\n* Medical condition(s) or medication(s) or herbal effects known to affect glucose regulation, tolerance or appetite and/or which influence digestion and absorption of nutrients (excluding oral contraceptives),\n* Use of steroids, protease inhibitors, amphetamines or antipsychotics'}, 'identificationModule': {'nctId': 'NCT07479251', 'briefTitle': 'Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants', 'orgStudyIdInfo': {'id': 'GCOS-015-CEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)', 'description': 'Participants will receive the test product and the control product alternately. They will be randomly assigned to one of the two treatment sequence groups with 15 participants in each group. The randomization will be stratified by race/ethnicity (Chinese, Caucasian).', 'interventionNames': ['Dietary Supplement: ONS', 'Other: glucose']}, {'type': 'OTHER', 'label': 'Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)', 'description': 'Participants will receive the test product and the control product alternately. They will be randomly assigned to one of the two treatment sequence groups with 15 participants in each group. The randomization will be stratified by race/ethnicity (Chinese, Caucasian).', 'interventionNames': ['Dietary Supplement: ONS', 'Other: glucose']}], 'interventions': [{'name': 'ONS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each administration of the test product (ONS) will represent 25 g of glycaemic carbohydrates.', 'armGroupLabels': ['Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)', 'Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)']}, {'name': 'glucose', 'type': 'OTHER', 'description': 'The test product will be compared with the reference product glucose (glucose monohydrate dissolved in 250 ml water). Each administration of the reference product will represent 25 g of glycaemic carbohydrates.', 'armGroupLabels': ['Group A (Treatment sequence: Glucose, ONS, Glucose, ONS, Glucose, ONS)', 'Group B (Treatment sequence: ONS, Glucose, ONS, Glucose, ONS, Glucose)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sangeetha Thondre, Dr', 'role': 'CONTACT', 'email': 'pthondre@brookes.ac.uk', 'phone': '+44 1865 534136'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oxford Brookes University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}