protocolSection identificationModule nctId: NCT06330636, orgStudyIdInfo id: 336-0723, briefTitle: The Acute Effect of D-allulose Consumption on Postprandial Glycaemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2024-03-28, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Nottingham, class: OTHER, descriptionModule briefSummary: The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose., conditionsModule conditions: Sugar; Blood, High, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised, placebo controlled cross over design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Allocation coded A and B, with independent researcher determining allocation and making up the test breakfasts for the study team., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: D-Allulose, interventions name: Sodium Saccharin, outcomesModule primaryOutcomes measure: Incremental area under the curve (iAUC) 180 Glucose Test, primaryOutcomes measure: iAUC 180 Glucose Placebo, secondaryOutcomes measure: Glycaemia Test, secondaryOutcomes measure: Glycaemia Placebo, secondaryOutcomes measure: Insulinemia Test, secondaryOutcomes measure: Insulinemia Placebo, secondaryOutcomes measure: iAUC 180 Insulin Test, secondaryOutcomes measure: iAUC 180 Insulin Placebo, secondaryOutcomes measure: iCAS Test, secondaryOutcomes measure: iCAS Placebo, secondaryOutcomes measure: abdominal discomfort test, secondaryOutcomes measure: abdominal discomfort placebo, secondaryOutcomes measure: Dietary Fibre, secondaryOutcomes measure: Carbohydrate %, secondaryOutcomes measure: Fat %, secondaryOutcomes measure: Protein %, secondaryOutcomes measure: Sugars %, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: David Greenfield Human Physiology Laboratories, city: Nottingham, state: Notts, zip: NG72UH, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False