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

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ClinicalTrials.gov Identifier: NCT02459535
Recruitment Status : Unknown
Verified November 2016 by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition.
Recruitment status was:  Recruiting
First Posted : June 2, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pre-diabetes Diabetes Other: oral stimulation glucose Other: oral stimulation saccharin Other: oral stimulation aspartame Other: oral stimulation sucralose Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. change in GIP release [ Time Frame: 120 mins ]
    comparison between all seven interventions

  2. change in GLP-1 release [ Time Frame: 120 mins ]
    comparison between all seven interventions

  3. change in GLP-2 release [ Time Frame: 120 mins ]
    comparison between all seven interventions

  4. change in PYY release [ Time Frame: 120 mins ]
    comparison between all seven interventions

  5. change in insulin release [ Time Frame: 120 mins ]
    comparison between all seven interventions

  6. 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

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459535


Contacts
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Contact: Stefan Kabisch, Dr. med. 030 450 514 ext 429 stefan.kabisch@charite.de
Contact: Andreas F.H. Pfeiffer, Prof. Dr. med. 033200 88 2771 afhp@dife.de

Locations
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Germany
German Institut for Human Nutrition; Department for Clinical Nutrition Recruiting
Nuthetal, Brandenburg, Germany, 14458
Contact: Margrit Kemper, Dr. med.    033200 88 2775    margrit.kemper@dife.de   
Sub-Investigator: Margrit Kemper, Dr. med.         
Sponsors and Collaborators
German Institute of Human Nutrition
Ludwig-Maximilians - University of Munich
More Information
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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Director, Department of Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02459535     History of Changes
Other Study ID Numbers: ILIAS-1
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
incretin release

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperglycemia
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs