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| ID | Type | Description | Link |
|---|---|---|---|
| DIABET NP 2009-PROYECTO CDTI | Other Identifier | VEGENAT, S.A. |
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The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).
This new complete diet has been carefully formulated, and incorporates functional ingredients based on:
The experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. Indeed, this product contains eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | The group 1 will receive the experimental product T-Diet plus Diabet NP for the first month followed by a reference diet corresponding to a current marketed product (Glucerna SR, Abbott) for the second month, then the patients will receive a control product non specific for diabetic patients (T-Diet plus Standard)for the third month, and finally a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the fourth month. |
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| Group 2 | Active Comparator | The group 2 will receive a reference diet corresponding to a current marketed product (Glucerna SR, Abbott)for the first month, followed by the experimental product T-Diet plus Diabet NP for the second month, then the patients will receive a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the third month, and finally a control product non specific for diabetic patients (T-Diet plus Standard)for the fourth month |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-Diet plus Standard | Dietary Supplement | T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status and Glycaemia |
| 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemicals parameters measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ángel Gil, PhD | Departament of Biochemistry and Molecular Biology II. University of Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biochemistry and Molecular Biology II. University of Granada | Granada | Granada | 18014 | Spain |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| C530986 | Glucerna |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| T-Diet plus Diabet NP | Dietary Supplement | T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. |
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| Glucerna | Dietary Supplement | GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance. |
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| Novasource | Dietary Supplement | Complete high protein diet for diabetic patients and hyperglycemic |
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| 9 months |
| Organic Chemicals |