No registrations found.
ID
Source
Brief title
Health condition
diabetes
taste perception
microbiota
Sponsors and support
Utrechtseweg 48. NL-3704 HE Zeist
Route de Pallatex 11, 1163 Etoy, Switzerland
Intervention
Outcome measures
Primary outcome
Differences between control and diabetes patients in:
- sweet detection threshold
- composition and diversity of the oral and gut microbiota
Secondary outcome
Differences between control and diabetes patients in:
- metabolic response to sweet by the gut
- the ways in which the above three parameters (sweet detection threshold, microbiota and metabolic response) relate to each other.
Study objective
The main objective of this study is to determine whether prediabetic individuals and those already diagnosed with type 2 diabetes show differences in sweet taste perception and whether this difference is related to their oral and/or gut microbiota composition.
Study design
not applicable
Intervention
in part of the study steviol glycosides
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7014 |
| NTR-old | NTR7212 |
| CCMO | NL63702.029.17 |
| OMON | NL-OMON46352 |