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

Primary Purpose

Diabetes, Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
custom-made soft drink
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring incretin release

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy

Exclusion Criteria:

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

Sites / Locations

  • German Institut for Human Nutrition; Department for Clinical Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Non-sweetened soft drink

Sweetened soft drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in release of GIP
change in fasting state and post-glucose release of GIP between the two interventions
change in release of GLP-1
change in fasting state and post-glucose release of GLP-1 between the two interventions
change in release of GLP-2
change in fasting state and post-glucose release of GLP-2 between the two interventions
change in release of PYY
change in fasting state and post-glucose release of PYY between the two interventions
change in release of insulin
change in fasting state and post-glucose release of insulin between the two interventions
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
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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2015
Last Updated
June 23, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02487537
Brief Title
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
Acronym
ILIAS-2
Official Title
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre-diabetes
Keywords
incretin release

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-sweetened soft drink
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Sweetened soft drink
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
custom-made soft drink
Primary Outcome Measure Information:
Title
change in release of GIP
Description
change in fasting state and post-glucose release of GIP between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in release of GLP-1
Description
change in fasting state and post-glucose release of GLP-1 between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in release of GLP-2
Description
change in fasting state and post-glucose release of GLP-2 between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in release of PYY
Description
change in fasting state and post-glucose release of PYY between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in release of insulin
Description
change in fasting state and post-glucose release of insulin between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Description
change in fasting state and post-glucose insulin secretion between the two interventions
Time Frame
4 weeks (cross-over)
Title
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Description
change in fasting state and post-glucose insulin sensitivity between the two interventions
Time Frame
4 weeks (cross-over)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy Exclusion Criteria: no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Facility Information:
Facility Name
German Institut for Human Nutrition; Department for Clinical Nutrition
City
Bergholz-Rehbrücke
State/Province
Brandenburg
ZIP/Postal Code
14458
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32449201
Citation
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
Results Reference
derived

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

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