diabetes T2D
Conditions
Interventions
Phase I study: not applicable. Phase II study: steviol glycosides are
administered to both groups.
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Able to speak, write and understand Dutch * Voluntary participation * Provided written informed consent * Willing to comply with the study procedures of phase 1 and phase 2 * Appropriate veins and circulation for blood sampling * Willing to accept use of all nameless data, including publication(s), and the confidential use and storage of all data for at least 15 years * Willing to accept the disclosures of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
Exclusion criteria: * Any significant medical reason for exclusion as determined by the investigator * Having a history of medical or surgical (gastrointestinal) events that may significantly affect the study outcome * Smoking * Other medication for diabetes than oral medication (i.e. Insulin) * Recent antibiotic medication (in the last 3 months) * Alcohol consumption > 21 units/week * Unable to give written informed consent * Not willing to give up blood donation during the study * Not having a general practitioner * Not willing to accept information transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/endpoints: * Differences between control and diabetes patients in: o sweet detection threshold o composition and diversity of the oral and gut microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: * Differences between control and diabetes patients in: o metabolic response to sweet by the gut o the ways in which the above three parameters (sweet detection threshold, microbiota and metabolic response) relate to each other | — |
Countries
Netherlands
Outcome results
None listed