Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT06135935
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In this double blind randomized controlled cross over design trial, patients will be randomized to receiving new KDD product or analog first. On the subsequent visit the opposite product will be provided.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2023-11-12', 'studyFirstSubmitQcDate': '2023-11-12', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams.', 'timeFrame': '8 months', 'description': 'The aim of this study is to test the postprandial glycemic response after consuming the new no added sugar-flavored ice cream compared to conventional products in patients with type 2 diabetes.'}], 'secondaryOutcomes': [{'measure': 'Plasma insulin responses over 120 minutes after consumption of the ice creams.', 'timeFrame': '8 months'}, {'measure': 'CGM monitor readouts over 24 hours after consumption of the ice creams.', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'no added sugar-flavored ice cream', 'conventional ice cream', 'postprandial glycemic response'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '39081682', 'type': 'DERIVED', 'citation': 'Al-Ozairi E, Mandani Y, Alfaleh G, Raj J, Alshammari S, Le Roux CW. Reformulating ice cream to improve postprandial glucose response: an opportunity for industry to create shared value. Front Nutr. 2024 Jul 16;11:1349392. doi: 10.3389/fnut.2024.1349392. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.', 'detailedDescription': 'The consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. The Metabolic Matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. This approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable.\n\nKDD is committed to addressing the pandemic of metabolic diseases in Kuwait and would like to develop products that benefit the collective metabolic health of the Kuwait population. KDD is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. We hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type 2 diabetes\n2. Aged over 18 years\n3. HbA1c 6.5-8.5% (48-69 mmol/L)\n\nExclusion Criteria:\n\n1. Lactose intolerant\n2. Not liking chocolate ice cream'}, 'identificationModule': {'nctId': 'NCT06135935', 'briefTitle': 'Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream', 'organization': {'class': 'OTHER', 'fullName': 'Dasman Diabetes Institute'}, 'officialTitle': 'Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products', 'orgStudyIdInfo': {'id': 'RA HM 2023-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No-added-sugar ice cream', 'description': 'KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. Four new flavored milks and four new ice creams all have no added sugar. Flavors include chocolate, vanilla, strawberry, and banana. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycemic index.', 'interventionNames': ['Other: No-added-sugar ice cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional products', 'description': 'KDD has been a leading manufacturer of food and beverages with added sugar (conventional products). The majority of people with type 2 diabetes consume their food products.', 'interventionNames': ['Other: Conventional products']}], 'interventions': [{'name': 'No-added-sugar ice cream', 'type': 'OTHER', 'description': 'The initial focus of this clinical trial will be the impact on postprandial glycaemia of 300g of ice cream, since, from a nutrition perspective, the flavored milks and ice creams are very similar in composition.', 'armGroupLabels': ['No-added-sugar ice cream']}, {'name': 'Conventional products', 'type': 'OTHER', 'description': 'The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.', 'armGroupLabels': ['conventional products']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15462', 'city': 'Kuwait City', 'state': 'Dasman', 'status': 'RECRUITING', 'country': 'Kuwait', 'contacts': [{'name': 'Ebaa Al Ozairi, MD', 'role': 'CONTACT', 'email': 'ebaa.alozairi@dasmaninstitute.org', 'phone': '22242999', 'phoneExt': '3111'}, {'name': 'Ebaa Al Ozairi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ghanima Alfaleh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carel Le Roux, MD, Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ebaa Al Ozairi', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'centralContacts': [{'name': 'Ebaa Al Ozairi', 'role': 'CONTACT', 'email': 'ebaa.alozairi@dasmaninstitute.org', 'phone': '22242999', 'phoneExt': '3111'}], 'overallOfficials': [{'name': 'Ebaa Al Ozairi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dasman Diabetes Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dasman Diabetes Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CMO', 'investigatorFullName': 'Dr. Ebaa Al Ozairi', 'investigatorAffiliation': 'Dasman Diabetes Institute'}}}}