Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-04 @ 5:08 PM
Study NCT ID:
NCT02352857
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic and Insulinaemic Responses After Consumption of FOS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-28', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic response', 'timeFrame': '2 hours and 5 minutes', 'description': 'Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.'}], 'secondaryOutcomes': [{'measure': 'Insulinaemic response', 'timeFrame': '2 hours and 5 minutes', 'description': 'Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin.'}, {'measure': 'Blood glucose peak (Cmax)', 'timeFrame': 'One-time data (the highest one) within the 2hrs 5mins kinetics.', 'description': 'Peak of blood glucose during kinetics.'}, {'measure': 'Blood insulin peak (Cmax)', 'timeFrame': 'One-time data (the highest one) within the 2hrs 5mins kinetics.', 'description': 'Peak of blood insulin during kinetics.'}, {'measure': 'Glucose Tmax : time to reach the peak of blood glucose', 'timeFrame': 'One time within the 2hrs 5mins kinetics.'}, {'measure': 'Insulin Tmax : time to reach the peak of blood insulin', 'timeFrame': 'One time within the 2hrs 5mins kinetics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fructo-oligosaccharides', 'Sugar-reduced foods', 'Postprandial glucose response'], 'conditions': ['Glycaemia']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) between 18.0 and 25.0 kg/m² (included);\n* Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit;\n* Be used to have breakfast;\n* Non-smoker for at least 3 months;\n* For the female participant: not being pregnant or breastfeeding and using efficient birth control;\n* Signed the consent form;\n* Able to follow the instructions of the study;\n* Health insured;\n* Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).\n\nExclusion Criteria:\n\n* Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not);\n* Fasting blood cholesterol over 6.35 mmol/L;\n* Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma);\n* Fasting blood insulin under 20 mU/L;\n* Fasting HbA1c under 7%;\n* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not;\n* History of dietary allergies or coeliac disease;\n* History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease;\n* Somatic or psychiatric disorders;\n* Renal insufficiency (kidney failure);\n* SGOT or ALAT over 52.5 U/L;\n* Smoker;\n* Consuming more than 3 alcoholic beverage a day;\n* Weight varied 3 kg the last 3 months."}, 'identificationModule': {'nctId': 'NCT02352857', 'acronym': 'GLYCOFOS-cake', 'briefTitle': 'Glycaemic and Insulinaemic Responses After Consumption of FOS.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Lille'}, 'officialTitle': 'Postprandial Glycaemic and Insulinaemic Responses After Consumption of Minicakes Containing FOS in Adults', 'orgStudyIdInfo': {'id': '2013-A00785-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar', 'description': 'Control group consuming sponge cakes containing in total 24g of dextrose.', 'interventionNames': ['Other: Sugar']}, {'type': 'EXPERIMENTAL', 'label': 'FOS', 'description': 'Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS.', 'interventionNames': ['Other: FOS']}], 'interventions': [{'name': 'Sugar', 'type': 'OTHER', 'description': '100g of sponge cakes made with 24g of dextrose.', 'armGroupLabels': ['Sugar']}, {'name': 'FOS', 'type': 'OTHER', 'description': '100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.', 'armGroupLabels': ['FOS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59019', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'NutrInvest - Institut Pasteur de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Jean-Michel LECERF, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Syral', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Endocrinologist, Nutritionist', 'investigatorFullName': 'Jean-Michel Lecerf', 'investigatorAffiliation': 'Institut Pasteur de Lille'}}}}