Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 (ILIAS-2)
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ClinicalTrials.gov Identifier: NCT02487537 |
Recruitment Status :
Completed
First Posted : July 1, 2015
Last Update Posted : June 24, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Pre-diabetes | Dietary Supplement: custom-made soft drink | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 |
Actual Study Start Date : | March 2015 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | July 2019 |
Arm | Intervention/treatment |
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Placebo Comparator: Non-sweetened soft drink
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
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Dietary Supplement: custom-made soft drink |
Active Comparator: Sweetened soft drink
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
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Dietary Supplement: custom-made soft drink |
- change in release of GIP [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose release of GIP between the two interventions
- change in release of GLP-1 [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose release of GLP-1 between the two interventions
- change in release of GLP-2 [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose release of GLP-2 between the two interventions
- change in release of PYY [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose release of PYY between the two interventions
- change in release of insulin [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose release of insulin between the two interventions
- change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose insulin secretion between the two interventions
- change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity [ Time Frame: 4 weeks (cross-over) ]change in fasting state and post-glucose insulin sensitivity between the two interventions

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487537
Germany | |
German Institut for Human Nutrition; Department for Clinical Nutrition | |
Bergholz-Rehbrücke, Brandenburg, Germany, 14458 |
Responsible Party: | Prof. Dr. med. Andreas F. H. Pfeiffer, Director, Department of Clinical Nutrition, German Institute of Human Nutrition |
ClinicalTrials.gov Identifier: | NCT02487537 |
Other Study ID Numbers: |
ILIAS-2 |
First Posted: | July 1, 2015 Key Record Dates |
Last Update Posted: | June 24, 2020 |
Last Verified: | June 2020 |
incretin release |
Diabetes Mellitus Prediabetic State Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |