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Completed

NCT Number: NCT02487537

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pre-diabetes

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy

Exclusion criteria

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

Treatment and study plan

custom-made soft drink

Dietary Supplement

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Acronym: ILIAS-2

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 1, 2015
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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