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

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.

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.

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.

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.

Study Type

Interventional

Enrollment (Actual)

10

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:

  • no 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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
Dietary supplement: custom-made soft drink
Active Comparator: Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
Dietary supplement: custom-made soft drink

What is the study measuring?

Primary Outcome Measures

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 30, 2015

First Posted (Estimate)

July 1, 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-2

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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