Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-29 @ 5:48 AM
Study NCT ID:
NCT04610203
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-25', 'size': 78723, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-10T13:49', 'hasProtocol': True}, {'date': '2018-11-27', 'size': 170783, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-10-10T13:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single-blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomised, repeat measure, crossover design trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood glucose response from baseline for 3 hours', 'timeFrame': '3 hours', 'description': 'Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours'}, {'measure': 'Change in plasma insulin response from baseline for 3 hours', 'timeFrame': '3 hours', 'description': 'Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours'}, {'measure': 'Area under the blood glucose concentration versus time curve', 'timeFrame': '3 hours', 'description': 'Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule'}, {'measure': 'Area under the plasma insulin concentration versus time curve', 'timeFrame': '3 hours', 'description': 'Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule'}, {'measure': 'Peak blood glucose concentration (Cmax)', 'timeFrame': '0-3 hours', 'description': 'Peak blood glucose concentration (Cmax) after consumption of the test food'}, {'measure': 'Peak plasma insulin concentration (Cmax)', 'timeFrame': '0-3 hours', 'description': 'Peak plasma insulin concentration (Cmax) after consumption of the test food'}, {'measure': 'Time of blood glucose peak (Tmax)', 'timeFrame': '0-3 hours', 'description': 'Time of blood glucose peak after consumption of the test food'}, {'measure': 'Time of plasma insulin peak (Tmax)', 'timeFrame': '0-3 hours', 'description': 'Time of plasma insulin peak after consumption of the test food'}], 'secondaryOutcomes': [{'measure': 'Change in GLP-1 from baseline for 3 hours', 'timeFrame': '3 hours', 'description': 'Change in GLP-1 from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours'}, {'measure': 'Change in GIP from baseline for 3 hours', 'timeFrame': '3 hours', 'description': 'Change in GIP from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours'}, {'measure': 'Area under the plasma GLP-1 concentration versus time curve', 'timeFrame': '3 hours', 'description': 'Area under the plasma GLP-1 concentration versus time curve was calculated by trapezoidal rule'}, {'measure': 'Area under the plasma GIP concentration versus time curve', 'timeFrame': '3 hours', 'description': 'Area under the plasma GIP concentration versus time curve was calculated by trapezoidal rule'}, {'measure': 'Peak plasma GLP-1 concentration (Cmax)', 'timeFrame': '0-3 hours', 'description': 'Peak plasma GLP-1 concentration (Cmax) after consumption of the test food'}, {'measure': 'Peak plasma GIP concentration (Cmax)', 'timeFrame': '0-3 hours', 'description': 'Peak plasma GIP concentration (Cmax) after consumption of the test food'}, {'measure': 'Time of plasma GLP-1 peak (Tmax)', 'timeFrame': '0-3 hours', 'description': 'Time of plasma GLP-1 peak after consumption of the test food'}, {'measure': 'Time of plasma GIP peak (Tmax)', 'timeFrame': '0-3 hours', 'description': 'Time of plasma GIP peak after consumption of the test food'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'availIpds': [{'url': 'http://drive.google.com/drive/folders/1H_y4bMle13r4wOG8YyapreznKUFG8cT_', 'type': 'Study Protocol'}, {'url': 'http://drive.google.com/drive/folders/1H_y4bMle13r4wOG8YyapreznKUFG8cT_', 'type': 'Informed Consent Form'}, {'url': 'http://drive.google.com/drive/folders/1H_y4bMle13r4wOG8YyapreznKUFG8cT_', 'type': 'Clinical Study Report'}, {'url': 'http://drive.google.com/drive/folders/1H_y4bMle13r4wOG8YyapreznKUFG8cT_', 'type': 'Individual Participant Data Set'}, {'url': 'http://drive.google.com/drive/folders/1H_y4bMle13r4wOG8YyapreznKUFG8cT_', 'type': 'Statistical Analysis Plan', 'comment': 'Included in the Study Protocol and Clinical Study report'}], 'references': [{'pmid': '20359723', 'type': 'BACKGROUND', 'citation': 'Siahanidou T, Margeli A, Kappis A, Papassotiriou I, Mandyla H. Circulating visfatin levels in healthy preterm infants are independently associated with high-density lipoprotein cholesterol levels and dietary long-chain polyunsaturated fatty acids. Metabolism. 2011 Mar;60(3):389-93. doi: 10.1016/j.metabol.2010.03.002. Epub 2010 Mar 31.'}], 'seeAlsoLinks': [{'url': 'http://www.iso.org/standard/43633.html', 'label': '23\\. Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.', 'detailedDescription': 'The aims of this study were to examine:\n\n* Phase I - the glycaemic response (GR) and insulinaemic response (IR) to:\n\n * 50 g available carbohydrate\n * 50 g available carbohydrate + protein (dose 1)\n * 50 g available carbohydrate + protein (dose 2)\n* Phase II - the GLP-1 and GIP response to:\n\n * 50 g available carbohydrate\n * 50 g available carbohydrate + protein (dose 1)\n * 50 g available carbohydrate + protein (dose 2)\n\nA single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases:\n\n* Phase I: glycaemic response (GR), insulinaemic response (IR)\n* Phase II: GLP-1 response and GIP response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 60 years\n* Body mass index (BMI) less than 30kg/m2\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Fasting blood glucose value \\> 6.1 mmol/l\n* Any known food allergy or intolerance\n* Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients\n* Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions\n* Major medical or surgical event requiring hospitalization within the preceding 3 months\n* Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).\n* Unable to comply with experimental procedures or did not follow GR testing safety guidelines.'}, 'identificationModule': {'nctId': 'NCT04610203', 'briefTitle': 'Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines', 'organization': {'class': 'OTHER', 'fullName': 'Oxford Brookes University'}, 'officialTitle': 'Glycaemic, Insulinaemic, Gastric Inhibitory Polypeptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Response for Glucose, Glucose With 25 g Nutralys S85 Plus and Glucose With 50 g Nutralys S85 Plus', 'orgStudyIdInfo': {'id': 'CPS 18-439'}, 'secondaryIdInfos': [{'id': 'pfact 9806', 'type': 'OTHER', 'domain': 'Oxford Brookes University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Glucose', 'description': 'Glucose - 50 g', 'interventionNames': ['Dietary Supplement: 50 g Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Nutralys S85 Plus 25 g', 'description': 'Nutralys S85 Plus Pea Protein 25 g + 50 g Glucose', 'interventionNames': ['Dietary Supplement: 25 g Nutralys Pea Protein']}, {'type': 'EXPERIMENTAL', 'label': 'Nutralys S85 Plus 50 g', 'description': 'Nutralys S85 Plus Pea Protein 50 g + 50 g Glucose', 'interventionNames': ['Dietary Supplement: 50 g Nutralys S85 Plus.']}], 'interventions': [{'name': '25 g Nutralys Pea Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus', 'armGroupLabels': ['Nutralys S85 Plus 25 g']}, {'name': '50 g Nutralys S85 Plus.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .', 'armGroupLabels': ['Nutralys S85 Plus 50 g']}, {'name': '50 g Glucose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose', 'armGroupLabels': ['Glucose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 0BP', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Brookes Centre for Nutrition and Health', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Sangeetha Thondre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford Brookes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford Brookes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roquette Freres', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Sangeetha Thondre', 'investigatorAffiliation': 'Oxford Brookes University'}}}}