Clinical trial NCT02459535: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Official title: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Diabetes
Keywords: incretin release
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2015-06-02
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

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

Primary outcomes:
measure: change in GIP release
timeFrame: 120 mins
measure: change in GLP-1 release
timeFrame: 120 mins
measure: change in GLP-2 release
timeFrame: 120 mins
measure: change in PYY release
timeFrame: 120 mins
measure: change in insulin release
timeFrame: 120 mins
measure: change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion
timeFrame: 120 mins
measure: change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
timeFrame: 120 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Bergholz-Rehbrücke
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
Study officials:
References: