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

Study Overview

• Status: Completed
• Conditions: Diabetes; Pre-diabetes
• Intervention / Treatment: Dietary supplement: custom-made soft drink

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Brandenburg
    • Bergholz-Rehbrücke, Brandenburg, Germany, 14458
      • German Institut for Human Nutrition; Department for Clinical Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in release of GIP	change in fasting state and post-glucose release of GIP between the two interventions	4 weeks (cross-over)
change in release of GLP-1	change in fasting state and post-glucose release of GLP-1 between the two interventions	4 weeks (cross-over)
change in release of GLP-2	change in fasting state and post-glucose release of GLP-2 between the two interventions	4 weeks (cross-over)
change in release of PYY	change in fasting state and post-glucose release of PYY between the two interventions	4 weeks (cross-over)
change in release of insulin	change in fasting state and post-glucose release of insulin between the two interventions	4 weeks (cross-over)
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	4 weeks (cross-over)
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	4 weeks (cross-over)

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: Ludwig-Maximilians - University of Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: incretin release
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: ILIAS-2