protocolSection identificationModule nctId: NCT06334302, orgStudyIdInfo id: RMC0362-23ctil, briefTitle: The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-25, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Rabin Medical Center, class: OTHER, collaborators name: Omega 3 Galilee, descriptionModule briefSummary: Omega Galil has developed a novel fatty sweetener that allows the use of up to 80% less sugar (particularly sucrose) and yet achieves a natural sweet flavor, using a novel technology of milling the natural sucrose crystals together with oil and thus creating a micro-suspension of sugar in oil or fat. The suspension increases the surface area of the sugar particles and thus a lower quantity of sugar is required in order to reach an enhanced perception of sweetness at the sweet taste receptors in the mouth. Omega Galil provides fatty food products that use up to 80% less sucrose, while tasting as sweet as regular sugar sweetened foods, with no aftertastes of sugar substitutes, and no chemical modifications or additives.Postprandial glucose (PPG) excursions in Type 1 Diabetes happen mainly due to a delay in subcutaneous insulin absorption and action, but also among other factors, depend on the meal composition. The glycemic index (GI) ranks foods based on acute glycemic response over a 2-h period of 50 g of available carbohydrates (CHO) of a test food compared with the reference standard glucose. Glycemic Load (GL) is a GI-weighted measure of carbohydrate content, which estimates the impact of carbohydrate intake using the GI while taking into account the amount of carbohydrates that are eaten in a serving. Several studies have demonstrated differences in PPG after consumption of low versus high GI meals, with rapid glucose spikes following high GI meals . Helping people with T1D achieve a diet with a lower glycemic load can improve both their quality of life and their diabetes-associated complications.The proposed randomized, double blind, cross-over, active control, clinical trial aims to:1. compare the glycemic response of T1D subjects to 20 grams of the O'Sweet sugar-reduced spread containing 8% sugar and a total of 1.6 grams of sucrose per meal, with their glycemic response to 20 grams of control Nutella spread, containing 56% sugar and a total of 11 grams sucrose per meal.2. compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella)., conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread", interventions name: Active Control-Nutella hazelnut cocoa spread, outcomesModule primaryOutcomes measure: Delta postprandial glucose level, secondaryOutcomes measure: Incremental area under the curve (iAUC), secondaryOutcomes measure: Peak postprandial glucose level, secondaryOutcomes measure: Time in range (TIR) of 70-180 mg/dl, secondaryOutcomes measure: Percentage of subjects who reached the desired glucose target, secondaryOutcomes measure: The percentage of time spent above 180 mg/dl, secondaryOutcomes measure: The percentage of time spent above 250 mg/dl, secondaryOutcomes measure: The percentage of time spent above 350 md/dl, secondaryOutcomes measure: Labeled Magnitude Scale (gLMS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Schneider Children Medical Center of Israel, status: RECRUITING, city: Petach-Tikva, country: Israel, contacts name: Alona Hamou, MSc, role: CONTACT, phone: 972-545-950-277, email: alonah@clalit.org.il, geoPoint lat: 32.08707, lon: 34.88747, hasResults: False