Diabetes, Pre-diabetes
Conditions
Keywords
incretin release
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.
Interventions
DIETARY_SUPPLEMENTcustom-made soft drink
Sponsors
Ludwig-Maximilians - University of Munich
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy
Exclusion criteria
* no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in release of GIP | 4 weeks (cross-over) | change in fasting state and post-glucose release of GIP between the two interventions |
| change in release of GLP-1 | 4 weeks (cross-over) | change in fasting state and post-glucose release of GLP-1 between the two interventions |
| change in release of GLP-2 | 4 weeks (cross-over) | change in fasting state and post-glucose release of GLP-2 between the two interventions |
| change in release of PYY | 4 weeks (cross-over) | change in fasting state and post-glucose release of PYY between the two interventions |
| change in release of insulin | 4 weeks (cross-over) | change in fasting state and post-glucose release of insulin between the two interventions |
| change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion | 4 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 sensitivity | 4 weeks (cross-over) | change in fasting state and post-glucose insulin sensitivity between the two interventions |
Countries
Germany
Outcome results
None listed