INQUIS Clinical Research
Toronto, Ontario, M5C 2N8, Canada
NCT Number: NCT05185960
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5C 2N8, Canada
Each subject will receive 3 test meals in a double blinded, randomized, crossover fashion.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water.
ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water.
Table sugar. It will be consumed by diluting it in water.
Time frame: Acute response over 2 hours
Compare the postprandial glucose incremental area under the curve response of ALLSWEET® with sucrose when taken alone or when added to sucrose.
Time frame: Acute response over 2 hours
Compare the postprandial glucose levels at each time point after each test meal.
Time frame: Acute response over 2 hours
Compare the postprandial insulin levels at each time point and incremental area under teh curve after each meal.
Anderson Advanced Ingredients
Industry
Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose: A Randomized, Double Blind, Controlled Clinical Trial in Healthy Individuals
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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