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| Name | Class |
|---|---|
| Cargill | INDUSTRY |
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The objectives of this trial are to assess the effects of steviol glycoside alone or in combination with a glycemic carbohydrate on blood glucose and endocrine and gut hormone secretion vs. water and glucose in individuals with normal weight, overweight and type 2 diabetes mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Weight Group | Experimental | The normal weight group incudes men and women with BMI 18.5 - 24.9 kg/m2, and will receive all interventions. |
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| Overweight Group | Experimental | The overweight group includes men and women with BMI 25.0 - 29.9 kg/m2, and will receive all interventions. |
|
| Type 2 Diabetes Mellitis Group | Experimental | The T2DM group includes men and women with BMI 25.0 - 34.9 kg/m2, HbA1c <8%, and will receive all interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water | Other | Each subject will receive one control and three treatments in the crossover design. The control contains water only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin | Changes or percent changes from baseline to the end of treatment | 4 weeks |
| Glucose | Changes or percent changes from baseline to the end of treatment | 4 weeks |
| Glucagon | Changes or percent changes from baseline to the end of treatment | 4 weeks |
| Peptide YY | Changes or percent changes from baseline to the end of treatment | 4 weeks |
| Glucagon-like peptide 1 | Changes or percent changes from baseline to the end of treatment | 4 weeks |
| Gastric inhibitory polypeptide | Changes or percent changes from baseline to the end of treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | MB Clinical Research & Consulting, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excellence Medical and Research | Miami Gardens | Florida | 33169 | United States | ||
| Advanced Research for Health Improvement |
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| Glucose | Other | Each subject will receive one control and three treatments in the crossover design. The glucose contains water and glucose. |
|
| Steviol Glycosides | Other | Each subject will receive one control and three treatments in the crossover design. The Steviol Glycoside beverage contains water and steviol glycosides. |
|
| Steviol Glycosides plus glucose | Other | Each subject will receive one control and three treatments in the crossover design. The Steviol Glycoside plus glucose beverage contains water, glucose, and steviol glycosides. |
|
| Rebaudioside A | Other | A leaf-based, extracted stevia product to compare to the Eversweet in the normal weight group only. The Rebaudioside A contains water and rebaudioside A. |
|
| Naples |
| Florida |
| 34102 |
| United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60625 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| D005947 | Glucose |
| C025474 | rebaudioside A |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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