Reference Values for Gastric Emptying

Study Overview
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Brief Summary
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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
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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.

Official Title
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Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal

Conditions
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Delayed Gastric Emptying

Intervention / Treatment
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* Other: Solid test meal, liquid test meal on two separate occations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: gastric emptying measurements<br> | Other: Solid test meal, liquid test meal on two separate occations<br>* 13C labeld solid test meal, 13C labeld liquid test meal on two separate occations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos) |  | 4 hours after test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |