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| Name | Class |
|---|---|
| Lund University | OTHER |
| Aventure AB | INDUSTRY |
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It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo drink | Placebo Comparator | A standardized breakfast meal will be provided together with carbonated water containing aroma |
|
| 5AA+CrPic Water Dose 1 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic |
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| 5AA+CrPic Water Dose 2 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic |
|
| 5AA+CrPic Water Dose 3 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5AA+CrPic Water | Dietary Supplement | Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose response | The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal. | 3h postprandial phase |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of capillary blood glucose | The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between 5AA+CrPic test products and the placebo following a standardized meal. | 3h postprandial phase |
| Serum insulin response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elin Östman, PhD | Scheelevägen 22 223 63 Lund, Sweden | Principal Investigator |
| Kristina Andersson, PhD | Experimental Medical Science, Lund University, Sweden | Study Director |
| Lovisa Heyman-Lindén, PhD | Scheelevägen 22 223 63 Lund, Sweden | Study Chair |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo drink | Other | Placebo water with carbonation and aroma |
|
The difference of the three-hour iAUC (0 - 180 min) intravenous serum insulin iAUC between 5AA+CrPic test products and the placebo following a standardized meal.
| 3h postprandial phase |
| Venous blood glucose response | The difference of the three-hour iAUC (0 - 180 min) intravenous plasma glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal. | 3h postprandial phase |
| GLP-1 response | The difference of the 1h iAUC (0 - 60 min) intravenous blood glucagon-like peptide 1 (GLP-1) iAUC between 5AA+CrPic test products and the placebo following a standardized meal. | 1h postprandial phase |
| Capillary blood glucose response | The difference in the two-hour iAUC (0 - 120 min) capillary blood glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal. | 2h postprandial phase |