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| Name | Class |
|---|---|
| Ingredion Incorporated | INDUSTRY |
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This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control bar (0 g fiber) | Placebo Comparator | Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit. |
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| Medium-fiber bar | Experimental | Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit. |
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| High-fiber bar | Experimental | Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium-fiber bar | Other | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the incremental area under the curve for capillary glucose. | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose. | Up to 120 minutes - measured at each treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the incremental area under the curve for venous glucose. | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose. | Up to 120 minutes - measured at each treatment visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | MB Clinical Research and Consulting LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MB Clinical Research | Boca Raton | Florida | 33487 | United States | ||
| Great Lakes Clinical Trials |
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Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
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The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code.
| High-fiber bar | Other | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. |
|
| Control bar (0 g fiber) | Other | Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. |
|
| Change in the incremental area under the curve for venous insulin. | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin. | Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose. |
| Chicago |
| Illinois |
| 60640 |
| United States |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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