Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05185960
Brief Summary:
This study will explore the postprandial glycemic response of ALLSWEET®, a non-GMO certified allulose, when consumed alone or with sucrose, compared to the consuming sucrose alone. On 3 separate days, subjects will consume in random order ALLSWEET® alone, ALLSWEET® added to sucrose, or sucrose alone. Blood samples for glucose and insulin analysis with be taken for 2 hours following consumption of the beverages.
Detailed Description:
Each subject will receive 3 test meals in a double blinded, randomized, crossover fashion.
1. Test arm 1: 30g sucrose
2. Test arm 2: 30g sucrose + 15g of ALLSWEET®
3. Test arm 3: 15g ALLSWEET® All sweeteners will be mixed with 250ml of water.
Eligible subjects will be studied on 3 separate days over a period of 4 weeks or less, with at least 1 day in between test days. A fasting fingerprick blood sample will be collected for glucose and insulin analysis after which the test meal will be administered. Additional fingerprick blood samples will be drawn over the next 2 hours (15', 30', 45', 60', 90' and 120' after the first sip of the test drink).
Power calculation: A sample size of 15 subjects, is sufficient to detect a 25% difference in incremental area under the curve between meals with 80% statistical power.
Statistical Analysis: Incremental area under the curve values, blood glucose and insulin concentrations and increments at each time will be subjected to repeated-measures analysis of variance. After demonstration of significant heterogeneity, the significance of the differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons, with the criterion for significance being two-tailed p\<0.05. Means which differ by more than the least significant difference differ significantly.
Study:
NCT05185960
Study Brief:
Protocol Section:
NCT05185960