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This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nutrition Supplement A | Active Comparator | Product containing calories from carbohydrate, protein, and fat |
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| Oral Nutrition Supplement B | Active Comparator | Product containing calories from carbohydrate, protein, and fat |
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| Oral Nutrition Supplement C | Active Comparator | Product containing calories from carbohydrate, protein, and fat |
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| Oral Nutrition Supplement D | Active Comparator | Product containing calories from carbohydrate, protein, and fat |
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| Oral Nutrition Supplement E | Active Comparator | Product containing calories from carbohydrate, protein, and fat |
|
| Oral Nutrition Supplement F | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutrition Supplement | Other | Product intake of oral nutrition supplement provided |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the blood glucose curve (ACU 0-240 minutes) | 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 [Change in Ins30/Change in Glu30] | [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes] |
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Subject inclusion criteria
All subjects must comply with all the following inclusion criteria:
Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.
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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 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
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Study staff will not be blinded to product assignment. Study participants will be blinded to product assignment. Product will be provided in unlabeled plastic cups.
Product containing calories from carbohydrate, protein, and fat |
|
| D004700 | Endocrine System Diseases |