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Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1

Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02459535
Acronym
ILIAS-1
Enrollment
14
Registered
2015-06-02
Start date
2015-03-31
Completion date
2019-07-31
Last updated
2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Pre-diabetes

Keywords

incretin release

Brief summary

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.

Detailed description

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.

Interventions

OTHERoral stimulation glucose

oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion

OTHERoral stimulation saccharin
OTHERoral stimulation aspartame
OTHERoral stimulation sucralose

Sponsors

Ludwig-Maximilians - University of Munich
CollaboratorOTHER
German Institute of Human Nutrition
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy

Exclusion criteria

* metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Design outcomes

Primary

MeasureTime frameDescription
change in GIP release120 minscomparison between all seven interventions
change in GLP-1 release120 minscomparison between all seven interventions
change in GLP-2 release120 minscomparison between all seven interventions
change in PYY release120 minscomparison between all seven interventions
change in insulin release120 minscomparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion120 minscomparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity120 minscomparison between all seven interventions

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026