Delayed Gastric Emptying
Conditions
Brief summary
Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air will be followed. Normal values will be calculated data of these tests.
Detailed description
This is a clinical study for establishing reference values in a 13C-octanoate breath test and a 13C-sodium acetate breath test. Healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13C-octanoate. 13C-content of exhaled air will be measured at baseline and followed for the next 4 hours. One week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (Ensure Plus Vanille, Abbott) containing 13C-sodium acetate. 13C-content of exhaled air will be measured at baseline and for the next 4 hours. Estimated gastric emptying time will be calculated using established algorithms.
Interventions
OTHERSolid test meal, liquid test meal on two separate occations
13C labeld solid test meal, 13C labeld liquid test meal on two separate occations
Sponsors
University of Bern
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects free of relevant abdominal complaints * Written informed consent
Exclusion criteria
* Age under 18 * Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders) * Known diabetes mellitus, scleroderma, neurological impairment or other major current disease * Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics * Pregnancy beyond week 12 (no pregnancy test will be performed) * Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion * Known allergy or intolerance against hen egg protein or gluten
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos) | 4 hours after test meal |
Secondary
| Measure | Time frame |
|---|---|
| t50 according to Bluck & Coward (t50_Bluck) | 4 hours after test meal |
| t50 according to Wagner & Nelson (t50_WN) | 4 hours after test meal |
| Gastric emptying coefficient (GEC) | 4 hours after test meal |
Countries
Switzerland
Outcome results
None listed