Skip to main content
OpenTrials
Completed

NCT Number: NCT02459535

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-diabetes Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy

Exclusion criteria

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

Treatment and study plan

oral stimulation glucose

Other

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

Other

oral stimulation aspartame

Other

oral stimulation sucralose

Other

Primary outcomes

  1. change in GIP release

    Time frame: 120 mins

    comparison between all seven interventions

  2. change in GLP-1 release

    Time frame: 120 mins

    comparison between all seven interventions

  3. change in GLP-2 release

    Time frame: 120 mins

    comparison between all seven interventions

  4. change in PYY release

    Time frame: 120 mins

    comparison between all seven interventions

  5. change in insulin release

    Time frame: 120 mins

    comparison between all seven interventions

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Acronym: ILIAS-1

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jun 2, 2015
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.