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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.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
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.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-sweetened soft drink | Placebo Comparator | 4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance |
|
| Sweetened soft drink | Active Comparator | 4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| custom-made soft drink | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in release of GIP | change in fasting state and post-glucose release of GIP between the two interventions | 4 weeks (cross-over) |
| change in release of GLP-1 | change in fasting state and post-glucose release of GLP-1 between the two interventions | 4 weeks (cross-over) |
| change in release of GLP-2 | change in fasting state and post-glucose release of GLP-2 between the two interventions | 4 weeks (cross-over) |
| change in release of PYY | change in fasting state and post-glucose release of PYY between the two interventions | 4 weeks (cross-over) |
| change in release of insulin | change in fasting state and post-glucose release of insulin between the two interventions | 4 weeks (cross-over) |
| change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion | change in fasting state and post-glucose insulin secretion between the two interventions | 4 weeks (cross-over) |
| change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity | change in fasting state and post-glucose insulin sensitivity between the two interventions | 4 weeks (cross-over) |
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Inclusion Criteria:
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32449201 | Derived | Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D006943 | Hyperglycemia |