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

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ClinicalTrials.gov Identifier: NCT02487537
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 : July 1, 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.

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.


Condition or disease Intervention/treatment Phase
Diabetes Pre-diabetes Dietary Supplement: custom-made soft drink 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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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. 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

  5. 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

  6. 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

  7. 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


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:

  • no 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): NCT02487537


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: NCT02487537     History of Changes
Other Study ID Numbers: ILIAS-2
First Posted: July 1, 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