Clinical trial NCT02487537: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
Official title: Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Pre-diabetes
Keywords: incretin release
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2015-07-01
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

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

Primary outcomes:
measure: change in release of GIP
timeFrame: 4 weeks (cross-over)
measure: change in release of GLP-1
timeFrame: 4 weeks (cross-over)
measure: change in release of GLP-2
timeFrame: 4 weeks (cross-over)
measure: change in release of PYY
timeFrame: 4 weeks (cross-over)
measure: change in release of insulin
timeFrame: 4 weeks (cross-over)
measure: change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
timeFrame: 4 weeks (cross-over)
measure: change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
timeFrame: 4 weeks (cross-over)
Secondary outcomes:
Other outcomes:
Locations:
city: Bergholz-Rehbrücke
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
Study officials:
References:
citation: 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.