Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 5:18 AM
Study NCT ID:
NCT05372666
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Index of Fibre-rich Flours in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Latin square randomization for test products following reference treatment (as per standard protocol)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2022-05-09', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic index', 'timeFrame': 'glycemia measured over 120 minutes', 'description': 'percentage area under the curve compared to standard white bread as 100% reference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a Body Mass Index (BMI) between 18.5 and 30 kg/m²\n* Non-smoker for more than three months\n* Having signed the informed consent form\n* Likely to follow the constraints generated by the study (one morning per week for 9 weeks)\n* Social insurance\n\nExclusion Criteria:\n\n* Pregnant woman\n* Subject with a known progressive somatic or psychiatric disease\n* Fasting blood glucose greater than 6.1 mmol/L (1.10 g/L), postprandial blood glucose greater than 7.7 mmol/L (1.4 g/L) or known diabetes treated or untreated\n* Hyperinsulinemia or a history of insulinoma\n* HbA1c greater than 7 %\n* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance\n* History of food allergy or digestive pathology likely to affect digestion or absorption\n* Renal failure\n* ASAT or ALAT elevation beyond 1.5 times the upper limit\n* Subject consuming more than three glasses per day of alcohol or suffering from various addictions\n* Weight change of more than 3 kg in the last three months\n* Person participating in another clinical study, or in a period of exclusion from another study\n* Person deprived of liberty or under judicial protection'}, 'identificationModule': {'nctId': 'NCT05372666', 'briefTitle': 'Glycaemic Index of Fibre-rich Flours in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paulic Meunerie SA'}, 'officialTitle': 'Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Qualista-IG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control IG100', 'description': '1 small bread loaf using T55 standard white flour for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Standard white bread']}, {'type': 'EXPERIMENTAL', 'label': 'Reference WB', 'description': '1 small bread loaf using T55 Qualista white flour for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Experimental white bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference HFB', 'description': '1 small bread loaf using T55 standard white flour supplemented with 11 % standard wheat bran (6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Standard High-fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'Qualista HFB 01', 'description': '1 small bread loaf using T55 Qualista white flour supplemented with 13 % untreated Qualista wheat bran (6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Experimental High-fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'Qualista HFB 02', 'description': '1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment A - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Experimental High-fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'Qualista HFB 03', 'description': '1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment B - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Experimental High-fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'Qualista HFB 04', 'description': '1 small bread loaf using T55 Qualista white flour supplemented with 13 % pretreated Qualista wheat bran (treatment C - 6% dietary fiber content) for a final content of 50 g equivalent digestible carbohydrates', 'interventionNames': ['Other: Experimental High-fiber bread']}], 'interventions': [{'name': 'Standard white bread', 'type': 'OTHER', 'description': 'Bread to be consumed within 10 minutes after 10h fasting', 'armGroupLabels': ['Control IG100']}, {'name': 'Experimental white bread', 'type': 'OTHER', 'description': 'Bread to be consumed within 10 minutes after 10h fasting', 'armGroupLabels': ['Reference WB']}, {'name': 'Standard High-fiber bread', 'type': 'OTHER', 'description': 'Bread to be consumed within 10 minutes after 10h fasting', 'armGroupLabels': ['Reference HFB']}, {'name': 'Experimental High-fiber bread', 'type': 'OTHER', 'description': 'Bread to be consumed within 10 minutes after 10h fasting', 'armGroupLabels': ['Qualista HFB 01', 'Qualista HFB 02', 'Qualista HFB 03', 'Qualista HFB 04']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'Centre de recherche clinique - Centre Hospitalo Universitaire', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paulic Meunerie SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institut Polytechnique UniLaSalle', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}