A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying

Study Overview
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Brief Summary
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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.

Official Title
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A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying During Continuous Nutrient Infusion

Conditions
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Healthy, Gastric Emptying

Intervention / Treatment
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* Diagnostic Test: 13C-octanoate breath test for gastric emptying


Participation Criteria
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Eligibility Criteria
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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

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A single blind, randomized, crossover monocentric study in a cohort of adult healthy volunteers
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Concentration A<br>Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml | Diagnostic Test: 13C-octanoate breath test for gastric emptying<br>* 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.<br>|
| Other: Concentration B<br>Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml | Diagnostic Test: 13C-octanoate breath test for gastric emptying<br>* 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.<br>|
| Other: Concentration C<br>Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml | Diagnostic Test: 13C-octanoate breath test for gastric emptying<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hourly 13C-recovery | Indicator for gastric emptying rate | 8 hour |