Reference Values for Gastric Emptying

University of Zurich75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Delayed Gastric Emptying

Interventions

Solid test meal, liquid test meal on two separate occationsOTHER

13C labeld solid test meal, 13C labeld liquid test meal on two separate occations

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)

Time frame: 4 hours after test meal

Secondary Outcomes

t50 according to Bluck & Coward (t50_Bluck)

Time frame: 4 hours after test meal

t50 according to Wagner & Nelson (t50_WN)

Time frame: 4 hours after test meal

Gastric emptying coefficient (GEC)

Time frame: 4 hours after test meal

Data from ClinicalTrials.gov

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