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| Name | Class |
|---|---|
| BioFortis | OTHER |
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The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soda consumption in fasted state | Experimental | One 12oz serving of soda consumed alone after a 4 hour fasting period |
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| Soda consumption with a defined carbohydrate rich meal | Experimental | One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLIPOP prebiotic soda | Other | 12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus*, Marshmallow Root*, Calendula Flower*, Kudzu Root*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root*, Stevia Leaf*, Himalayan Pink Salt, Green Tea Caffeine*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon* (*Extract) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose iAUC | Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence). | For 2 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Cmax | Blood glucose maximum concentration | For 2 hours post intervention |
| Time to Blood Glucose Cmax (Tmax) | Time to maximum blood glucose concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Addison | Illinois | 60101 | United States |
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| Traditional sugar-sweetened cola | Other | 12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine |
|
| For 2 hours post intervention |
| Blood Glucose Rise 0-2 Hours | The maximum concentration above the average baseline glucose concentration within the 2-hour period following study product consumption, expressed as a percentage of the average baseline glucose concentration | For 2 hours post intervention |
| Blood Glucose Dip 2-3 Hours | The difference between the lowest glucose concentration in hours 2-3 after study product consumption and the average baseline glucose concentration, expressed as a percentage of average baseline glucose concentration | For time frame of 2 to 3 hours post intervention |
| Blood Glucose Reduction | The number of participants with a reduction in glucose in hours 2-3 after study product consumption compared to the average baseline glucose concentration | For time frame of 2 to 3 hours post intervention |
| Time Until Next Meal | The number of minutes after consumption of the study product that elapsed before the next meal of at least 50 kcal is consumed | Within same day post interevention |
| Energy Intake - Short Term | Energy intake (kcals) within 3 to 4 hours post-product consumption | For time frame of 3 to 4 hours post intervention |
| Energy Intake - 24 Hours | The total daily consumption covers the full period from 4 hours before the participant's breakfast to 20 hours after | Time frame from 4 hours before the participant's breakfast to 20 hours after participant's breakfast |
| Change in Perceived Hunger Level | The change in hunger ratings from pre-meal to post meal where post meal is defined as the average of the hunger ratings in the 2- 3 hour time frame | For time frame of 2 to 3 hours post intervention |
| Change in Perceived Alertness Level | The change in alertness ratings from pre-meal to post meal where the post meal is defined as the average alertness ratings in the 2-3 hour time frame | For time frame of 2 to 3 hours post intervention |