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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal replacement shake | Experimental | Teatis meal replacement shake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal replacement shake | Dietary Supplement | Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of quality of life score from baseline to 12-weeks | Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in a1c levels from baseline to 12-weeks | Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Improvement in blood glucose from baseline to 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke, MSc | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | 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 is an open-label single-arm observational trial
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Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
| 12 weeks |
| Improvement in insulin levels from baseline to 12-weeks | Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Improvement in total cholesterol levels from baseline to 12-weeks | Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Improvement in triglyceride levels from baseline to 12-weeks | Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Improvement in HDL cholesterol levels from baseline to 12-weeks | Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Improvement in LDL cholesterol levels from baseline to 12-weeks | Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| D004700 | Endocrine System Diseases |