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

June 23, 2020 updated by: Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Brandenburg
      • Bergholz-Rehbrücke, Brandenburg, Germany, 14458
        • German Institut for Human Nutrition; Department for Clinical Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Glucose only
oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
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
ACTIVE_COMPARATOR: Glucose + Saccharin
oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
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
Other: oral stimulation saccharin
ACTIVE_COMPARATOR: Saccharin only
oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Other: oral stimulation saccharin
ACTIVE_COMPARATOR: Glucose + Aspartame
oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
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
Other: oral stimulation aspartame
ACTIVE_COMPARATOR: Aspartame only
oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Other: oral stimulation aspartame
ACTIVE_COMPARATOR: Glucose + Sucralose
oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
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
Other: oral stimulation sucralose
ACTIVE_COMPARATOR: Sucralose only
oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Other: oral stimulation sucralose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in GIP release
Time Frame: 120 mins
comparison between all seven interventions
120 mins
change in GLP-1 release
Time Frame: 120 mins
comparison between all seven interventions
120 mins
change in GLP-2 release
Time Frame: 120 mins
comparison between all seven interventions
120 mins
change in PYY release
Time Frame: 120 mins
comparison between all seven interventions
120 mins
change in insulin release
Time Frame: 120 mins
comparison between all seven interventions
120 mins
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
120 mins
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
120 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Institute of Human Nutrition

Collaborators

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (ESTIMATE)

June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILIAS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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