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| Name | Class |
|---|---|
| Lund University | OTHER |
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It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water with amino acids and chromium | Active Comparator | The carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses. |
|
| Carbonated water | Placebo Comparator | The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbonated water with amino acids and chromium | Dietary Supplement | The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes | The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal |
| Measure | Description | Time Frame |
|---|---|---|
| The three-hour iAUC for insulin, 0-180 minutes | The incremental area under the curve for intravenous blood insulin will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal |
| The three hour iAUC for intravenous glucose, 0-180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin | Blood samples will be collected at 8 time points during the 180 minutes. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal |
| The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina E Andersson, PhD | Lund University and Aventure AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Experimental Medical Science, Lund University | Lund | Sweden |
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| Placebo Carbonated Water | Dietary Supplement | The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes |
|
The incremental area under the curve for intravenous blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes. |
| 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal |
| The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes | The incremental area under the curve for intravenous blood GLP-1 will be measured within 60 minutes after a test meal. Blood samples will be collected at 5 time points during the 60 minutes. | 0, 15, 30, 45 and 60 minutes post test meal |
Blood samples will be collected at 8 time points during the 180 minutes. |
| 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal |
| The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin | Blood samples will be collected at 7 time points during the 120 minutes. | 0, 15, 30, 45, 60, 90 and 120 minutes post test meal |
| The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin | Blood samples will be collected at 5 time points during the 60 minutes. | 0, 15, 30, 45 and 60 minutes post test meal |
| Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood. | A delta value will be calculated from samples collected at time=0 and time=60 minutes | 0 and 60 minutes post test meal |
| Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood. | A delta value will be calculated from samples collected at time=0 and time=120 minutes | 0 and 120 minutes post test meal |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061545 | Carbonated Water |
| D000596 | Amino Acids |
| D002857 | Chromium |
| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002253 | Carbonated Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D060766 | Drinking Water |
| D019602 | Food and Beverages |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
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