Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

Diabetes Clinical Trial

— ILIAS-2  

Official title:

Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487537
• Other study ID #: ILIAS-2
• 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.

Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.

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.

Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• 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:

• no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• custom-made soft drink

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 release of GIP	change in fasting state and post-glucose release of GIP between the two interventions	4 weeks (cross-over)
Primary	change in release of GLP-1	change in fasting state and post-glucose release of GLP-1 between the two interventions	4 weeks (cross-over)
Primary	change in release of GLP-2	change in fasting state and post-glucose release of GLP-2 between the two interventions	4 weeks (cross-over)
Primary	change in release of PYY	change in fasting state and post-glucose release of PYY between the two interventions	4 weeks (cross-over)
Primary	change in release of insulin	change in fasting state and post-glucose release of insulin between the two interventions	4 weeks (cross-over)
Primary	change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion	change in fasting state and post-glucose insulin secretion between the two interventions	4 weeks (cross-over)
Primary	change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity	change in fasting state and post-glucose insulin sensitivity between the two interventions	4 weeks (cross-over)