Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1 (ILIAS-1)
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ClinicalTrials.gov Identifier: NCT02459535 |
Recruitment Status :
Completed
First Posted : June 2, 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.
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.
Condition or disease | Intervention/treatment | Phase |
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Pre-diabetes Diabetes | Other: oral stimulation glucose Other: oral stimulation saccharin Other: oral stimulation aspartame Other: oral stimulation sucralose | 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.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1 |
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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Active Comparator: Glucose only
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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Other: oral stimulation glucose
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion |
Active Comparator: Glucose + Saccharin
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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Other: oral stimulation glucose
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion Other: oral stimulation saccharin |
Active Comparator: Saccharin only
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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Other: oral stimulation saccharin |
Active Comparator: Glucose + Aspartame
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
|
Other: oral stimulation glucose
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion Other: oral stimulation aspartame |
Active Comparator: Aspartame only
oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
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Other: oral stimulation aspartame |
Active Comparator: Glucose + Sucralose
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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Other: oral stimulation glucose
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion Other: oral stimulation sucralose |
Active Comparator: Sucralose only
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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Other: oral stimulation sucralose |
- change in GIP release [ Time Frame: 120 mins ]comparison between all seven interventions
- change in GLP-1 release [ Time Frame: 120 mins ]comparison between all seven interventions
- change in GLP-2 release [ Time Frame: 120 mins ]comparison between all seven interventions
- change in PYY release [ Time Frame: 120 mins ]comparison between all seven interventions
- change in insulin release [ Time Frame: 120 mins ]comparison between all seven interventions
- change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion [ Time Frame: 120 mins ]comparison between all seven interventions
- change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity [ Time Frame: 120 mins ]comparison between all seven 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:
- 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): NCT02459535
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: | NCT02459535 |
Other Study ID Numbers: |
ILIAS-1 |
First Posted: | June 2, 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 |