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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02459535
Other study ID # ILIAS-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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