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

Not Applicable
Completed
Conditions
Diabetes
Pre-diabetes
Interventions
Dietary Supplement: custom-made soft drink
Registration Number
NCT02487537
Lead Sponsor
German Institute of Human Nutrition
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
10
Inclusion Criteria
  • healthy
Exclusion Criteria
  • no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sweetened soft drinkcustom-made soft drink4-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
Non-sweetened soft drinkcustom-made soft drink4-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
Primary Outcome Measures
NameTimeMethod
change in release of GLP-14 weeks (cross-over)

change in fasting state and post-glucose release of GLP-1 between the two interventions

change in release of insulin4 weeks (cross-over)

change in fasting state and post-glucose release of insulin between the two interventions

change in release of PYY4 weeks (cross-over)

change in fasting state and post-glucose release of PYY between the two interventions

change in release of GIP4 weeks (cross-over)

change in fasting state and post-glucose release of GIP between the two interventions

change in release of GLP-24 weeks (cross-over)

change in fasting state and post-glucose release of GLP-2 between the two interventions

change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion4 weeks (cross-over)

change in fasting state and post-glucose insulin secretion between the two interventions

change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity4 weeks (cross-over)

change in fasting state and post-glucose insulin sensitivity between the two interventions

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

German Institut for Human Nutrition; Department for Clinical Nutrition

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Bergholz-Rehbrücke, Brandenburg, Germany

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