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The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).
This is a single-center randomized, single-blinded, cross-over design study to allow for three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing different amounts of resistant starch. The study will evaluate acute glucose and insulin response in healthy men and women aged 20-45 years.
The trial will initiate with record collection to assess background general health (screening visit) and dietary intake followed by counseling to follow a relatively low polyphenolic beverages/foods diet, and high fiber containing food (particularly fermentable) which will commence at least 3 days before randomization (washout) and continue for the duration of the study. After 3-day washout period, subjects will be randomized to treatment order within Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the consumption of cereal bars will be determined by blood collections via venous catheter. Blood samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and 15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and insulin concentrations in the plasma. The primary endpoint is glucose positive incremental area under the curve (positive iAUC- ignores area below fasting) among the three tests bars. Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin net incremental AUC (net iAUC). Adverse events also will be collected and frequency tabulated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cereal Bar no fiber | Placebo Comparator | Cereal bar without fiber |
|
| Cereal bar with 10 g fiber | Active Comparator | Cereal bar with 10 g fiber |
|
| Cereal bar with 20 g fiber | Active Comparator | Cereal bar with 20 g fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cereal Bar no fiber | Dietary Supplement | Cereal Bar no fiber |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Plasma Glucose concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours | Changes in plasma glucose concentration as measured by positive iAUC (ignoring area below fasting) over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment | Postprandial 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatments compared to control treatment | Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment | Postprandial 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Cereal bar with 10 g fiber |
| Dietary Supplement |
Cereal bar with 10 g fiber |
|
| Cereal bar with 20 g fiber | Dietary Supplement | Cereal bar with 20 g fiber |
|
| Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours | Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours | Postprandial 2 hours |
| Plasma Glucose maximal concentration (Cmax) over 2 hours | Plasma Glucose maximal concentration (Cmax) over 2 hours | Postprandial 2 hours |
| Plasma Insulin maximal concentration (Cmax) over 2 hours | Plasma Insulin maximal concentration (Cmax) over 2 hours | Postprandial 2 hours |
| Change in postprandial blood glucose concentration responses for treatments compared to control over 2-hour postprandial period | postprandial blood glucose concentration responses over 2 hours | Postprandial 2 hours |
| Change in postprandial blood insulin concentration responses for treatments compared to control over 2-hour postprandial period | postprandial blood insulin concentration responses over 2 hours | Postprandial 2 hours |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |