Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLSWEET® | Experimental | ALLSWEET® will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
|
| ALLSWEET® consumed with sucrose | Experimental | ALLSWEET® and sucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
|
| Sucrose | Active Comparator | Sucrose will be mixed with 250ml of water and an additional 125ml of water. Fingerprick blood samples will be taken for 2 hours following consumption of beverage in order to assess the glycemic response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLSWEET® | Other | ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic response | Compare the postprandial glucose incremental area under the curve response of ALLSWEET® with sucrose when taken alone or when added to sucrose. | Acute response over 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic response | Compare the postprandial glucose levels at each time point after each test meal. | Acute response over 2 hours |
| Postprandial insulinemic response | Compare the postprandial insulin levels at each time point and incremental area under teh curve after each meal. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INQUIS Clinical Research | Toronto | Ontario | M5C 2N8 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ALLSWEET® and sucrose | Other | ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water. |
|
| Sucrose | Other | Table sugar. It will be consumed by diluting it in water. |
|
| Acute response over 2 hours |
| D000073893 |
| Sugars |