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| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
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The main objective of this study is to evaluate the acute effects of prebiotic sodas on postprandial levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY), gastric emptying, and satiety levels in healthy adults.
The primary aim of this clinical trial is to evaluate the effects of single-dose prebiotic sodas on on postprandial levels of GLP-1.
Participants (n=15) will be healthy males and healthy, non-pregnant, non-lactating females aged 18-60 years. Participants will consume a single dose of 3 different prebiotic sodas (6 - 9 g dietary fiber and 4 g total sugar per can) and one control soda (0 g dietary fiber and 4 g total sugar per can) in a randomized, crossover design over a period of 4-12 weeks with an interval of at least 1 week and at most 3 weeks between visits.
Secondary outcomes will include evaluating the effects of single-dose consumption of the control and prebiotic sodas on postprandial PYY, gastric emptying, and satiety levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Soda | Placebo Comparator | Participants will consume one 12 oz can of a control soda |
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| Prebiotic Soda - Shelf Stable | Experimental | Participants will consume one 12 oz can of the shelf stable prebiotic soda |
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| Prebiotic Soda - Refrigerated | Experimental | Participants will consume one 12 oz can of the refrigerated prebiotic soda |
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| Prebiotic Soda - Shelf Stable + Functional Ingredient | Experimental | Participants will consume one 12 oz can of the shelf stable prebiotic soda with an added functional ingredient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Soda | Other | Participants will consume one 12 oz can of a control soda that contains 0 g dietary fiber and 4 g total sugar. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood GLP-1 iAUC | Incremental area under the curve (iAUC) for GLP-1 from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption. | For 2 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Blood PYY iAUC | Incremental area under the curve (iAUC) for PYY from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption. | For 2 hours post intervention |
| Gastric Emptying Rate/Transit Time via Acetaminophen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Contact | 416-861-0506 | 201 | jcampbell@inquis.com |
| Senior Scientist | Contact | 416-861-9782 | alexandrajenkins@inquis.com |
| Name | Affiliation | Role |
|---|---|---|
| Janice Campbell | INQUIS Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis Clinical Research | Recruiting | Toronto | Ontario | M5C 2N8 | Canada |
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| Prebiotic Soda - Shelf Stable | Other | Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber and 4 g total sugar. |
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| Prebiotic Soda - Refrigerated | Other | Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 9 g dietary fiber and 4 g total sugar. |
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| Prebiotic Soda - Shelf Stable + Functional Ingredient | Other | Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber, 4 g total sugar, and an added functional ingredient. |
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Incremental area under the curve (iAUC) for acetaminophen from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption. |
| Oral dose of acetaminophen with blood samples taken for 2 hours post intervention |
| Change in Perceived Satiety Levels | The change in perceived satiety levels measured using the Motivation to Eat visual analogue scale (VAS) from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption. | For 2 hours post intervention |
| ID | Term |
|---|---|
| C546054 | sodium bicarbonate-based toothpaste |
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