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

Primary Purpose

Pre-diabetes, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
oral stimulation glucose
oral stimulation saccharin
oral stimulation aspartame
oral stimulation sucralose
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring incretin release

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • 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 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Glucose only

Glucose + Saccharin

Saccharin only

Glucose + Aspartame

Aspartame only

Glucose + Sucralose

Sucralose only

Arm Description

oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins

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

oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins

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

oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins

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

oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Outcomes

Primary Outcome Measures

change in GIP release
comparison between all seven interventions
change in GLP-1 release
comparison between all seven interventions
change in GLP-2 release
comparison between all seven interventions
change in PYY release
comparison between all seven interventions
change in insulin release
comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion
comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
comparison between all seven 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
NCT02459535
Brief Title
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Acronym
ILIAS-1
Official Title
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
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. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose only
Arm Type
Active Comparator
Arm Description
oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Arm Title
Glucose + Saccharin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Saccharin only
Arm Type
Active Comparator
Arm Description
oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Arm Title
Glucose + Aspartame
Arm Type
Active Comparator
Arm Description
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
Arm Title
Aspartame only
Arm Type
Active Comparator
Arm Description
oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Arm Title
Glucose + Sucralose
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sucralose only
Arm Type
Active Comparator
Arm Description
oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
Intervention Type
Other
Intervention Name(s)
oral stimulation glucose
Intervention Description
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion
Intervention Type
Other
Intervention Name(s)
oral stimulation saccharin
Intervention Type
Other
Intervention Name(s)
oral stimulation aspartame
Intervention Type
Other
Intervention Name(s)
oral stimulation sucralose
Primary Outcome Measure Information:
Title
change in GIP release
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in GLP-1 release
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in GLP-2 release
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in PYY release
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in insulin release
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion
Description
comparison between all seven interventions
Time Frame
120 mins
Title
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Description
comparison between all seven interventions
Time Frame
120 mins

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: 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

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

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