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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
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Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose only | Active Comparator | oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| Glucose + Saccharin | Active Comparator | oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| Saccharin only | Active Comparator | oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| Glucose + Aspartame | Active Comparator | oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| Aspartame only | Active Comparator | oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral stimulation glucose | Other | oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in GIP release | comparison between all seven interventions | 120 mins |
| change in GLP-1 release | comparison between all seven interventions | 120 mins |
| change in GLP-2 release | comparison between all seven interventions | 120 mins |
| change in PYY release | comparison between all seven interventions | 120 mins |
| change in insulin release | comparison between all seven interventions | 120 mins |
| change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion | comparison between all seven interventions | 120 mins |
| change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity | comparison between all seven interventions | 120 mins |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institut for Human Nutrition; Department for Clinical Nutrition | Bergholz-Rehbrücke | Brandenburg | 14458 | Germany |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Glucose + Sucralose | Active Comparator | oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| Sucralose only | Active Comparator | oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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| oral stimulation saccharin | Other |
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| oral stimulation aspartame | Other |
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| oral stimulation sucralose | Other |
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| D004700 | Endocrine System Diseases |