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This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.
Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boost Glucose Control (A) | Experimental | Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes. |
|
| Boost Glucose Control (B) | Experimental | Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes. |
|
| Boost Original | Active Comparator | Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boost Glucose Control (A) | Other | Oral nutrition supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the blood glucose curve (AUC 0-240) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin curves (AUC 0-240) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | |
| Insulinogenic index (Ins30/(Glu30) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Neutel, MD | Orange County Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States |
Data will be presented in a peer reviewed manuscript
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Boost Glucose Control (B) |
| Other |
Oral nutrition supplement |
|
| Boost Original | Other | Oral nutrition supplement |
|
| AUC (0-30min) for insulin | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |