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

Not Applicable

Completed

• Conditions: Pre-diabetes; Diabetes

• Registration Number: NCT02459535
• Lead Sponsor: German Institute of Human Nutrition

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Primary Completion: 2017-06
• Study Completion: 2019-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• healthy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in GLP-1 release	120 mins	comparison between all seven interventions
change in PYY release	120 mins	comparison between all seven interventions
change in GIP release	120 mins	comparison between all seven interventions
change in GLP-2 release	120 mins	comparison between all seven interventions
change in insulin release	120 mins	comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion	120 mins	comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity	120 mins	comparison between all seven interventions

Trial Locations

Locations (1)

German Institut for Human Nutrition; Department for Clinical Nutrition; 🇩🇪 Bergholz-Rehbrücke, Brandenburg, Germany