Gastric Emptying, Healthy
Conditions
Brief summary
The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.
Interventions
DIAGNOSTIC_TEST13C-octanoate breath test for gastric emptying
The 13C-octanoate breath test for gastric emptying will be performed to assess gastric emptying rate of a liquid meal that is infused continuously over a period of 8 hour. 13C-labeled sodium octanoate (food adjective) is mixed with liquid nutrients used for enteral feeding. The concentration of 13C-labeled sodium octanoate is according to the randomized treatment order. This mixture is infused at 20 ml/h for 8 hours (hourly dose of 13C-octanoate differs between treatment arms). In order to estimate gastric emptying rate quantitatively throughout the infusion period, the appearance of 13CO2 in the breath, relative to 12CO2, will be monitored by sampling the exhaled breath at a 15 minute interval. The aim is to induce a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in future clinical investigations.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
A single blind, randomized, crossover monocentric study in a cohort of adult healthy volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent * At least 18 years old * BMI between and including 18 and 29 * Understand and able to read Dutch * In good health on the basis of medical history * Refrains from herbal, vitamin and other dietary supplements on the day of the visits
Exclusion criteria
* Dyspeptic symptoms (assessed with PAGI-SYM questionnaire, Annex II) * Using any medication that might affect gastric function or visceral sensitivity * Known / suspected current use of illicit drugs * Known psychiatric or neurological illness * Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator * History of heart or vascular diseases like irregular heartbeats, angina or heart attack * Nasopharyngeal surgery in the last 30 days * Suspected basal skull fracture or severe maxillofacial trauma * History of thermal or chemical injury to upper respiratory tract or esophagus * Current esophageal or nasopharyngeal obstruction * Known coagulopathy * Known esophageal varices * Have a known allergy or intolerance to cow milk, soy or any other ingredient of Isosource Standard. * Known galactosaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hourly 13C-recovery | 8 hour | Indicator for gastric emptying rate |
Countries
Belgium
Outcome results
None listed