Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Metabolic assessment will be based on oral glucose tolerance tests.

Official Title
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Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

Conditions
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Pre-diabetes, Diabetes

Intervention / Treatment
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* Dietary Supplement: custom-made soft drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy Exclusion Criteria: no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-sweetened soft drink<br>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 | Dietary Supplement: custom-made soft drink<br> <br> |
| Active Comparator: Sweetened soft drink<br>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 | Dietary Supplement: custom-made soft drink<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incretin release