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

Diabetes Clinical Trial

— ILIAS-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459535
• Other study ID #: ILIAS-1
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: June 2020
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pre-diabetes
• Prediabetic State

Intervention

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
• oral stimulation saccharin

• oral stimulation aspartame

• oral stimulation sucralose

Locations

Country	Name	City	State
Germany	German Institut for Human Nutrition; Department for Clinical Nutrition	Bergholz-Rehbrücke	Brandenburg

Sponsors (2)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in GIP release	comparison between all seven interventions	120 mins
Primary	change in GLP-1 release	comparison between all seven interventions	120 mins
Primary	change in GLP-2 release	comparison between all seven interventions	120 mins
Primary	change in PYY release	comparison between all seven interventions	120 mins
Primary	change in insulin release	comparison between all seven interventions	120 mins
Primary	change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion	comparison between all seven interventions	120 mins
Primary	change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity	comparison between all seven interventions	120 mins