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This will be a randomized crossover design with nutrition supplement interventions.
This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced Nutritional Drink | Active Comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition. |
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| Balanced Nutritional Drink - DMA | Active Comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes. |
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| Balanced Nutritional Drink - DMB | Active Comparator | The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced Nutritional Drink | Other | Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the blood glucose curve | Area under the blood glucose curve (AUC 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 | Area under the insulin curves (AUC 0-240) | Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
| Insulinogenic index | Insulinogenic index [Change in Ins30/Change in Glu30] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krysmaru Araujo Torres, MD | Nestle Health Science | Study Director |
| 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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| ID | Term |
|---|---|
| C084245 | HLA-DM antigens |
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This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.
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Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.
| Diabetes Specific, Balanced Nutritional Drink (DMA) | Other | Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting. |
|
| Diabetes Specific, Balanced Nutritional Drink DMB | Other | Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition. |
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| Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes |
| D004700 | Endocrine System Diseases |