Enteral Nutrition Infusion Rate and Gastric Function

Study Overview
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Brief Summary
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A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation. Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.

Official Title
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ANTERO-3: The Impact of Enteral Nutrition Infusion Rate on Gastric Motility and Gastric Emptying Rate, Measured With the VIPUN Balloon Catheter, Magnetic Resonance Imaging and the 13C-octanoate Breath Test.

Conditions
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Healthy

Intervention / Treatment
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* Device: VIPUN Balloon Catheter


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 30 Understand and able to read Dutch In good health on the basis of medical history Female subjects of childbearing potential are willing to use adequate contraception Refrains from herbal, vitamin and other dietary supplements on the day of the visits Exclusion Criteria: Dyspeptic symptoms (assessed with PAGI-SYM questionnaire) 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 History of thermal or chemical injury to upper respiratory tract or esophagus Current esophageal or nasopharyngeal obstruction Known coagulopathy Known esophageal varices Metal or other MRI incompatible implants Contra-indications for MR (checked by MR safety questionnaire) Pregnancy Claustrophobia Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.

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: Three-way crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition A<br>Infusion rate = 25 ml/h Radiography: confirmation balloon position VIPUN Balloon Catheter 13C-Octanoate Breath Test o | Device: VIPUN Balloon Catheter<br>* The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.<br>* Other names: VIPUN system;|
| Experimental: Condition B<br>Infusion rate = 75 ml/h Magnetic resonance imaging VIPUN Balloon Catheter 13C-Octanoate Breath Test | Device: VIPUN Balloon Catheter<br>* The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.<br>* Other names: VIPUN system;|
| Experimental: Condition C<br>Infusion rate = 250 ml/h Magnetic resonance imaging VIPUN Balloon Catheter 13C-Octanoate Breath Testt | Device: VIPUN Balloon Catheter<br>* The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.<br>* Other names: VIPUN system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motility | Motility index (MI) measured with the VIPUN Balloon Catheter. | 8 hour | 
| Gastric emptying rate (13C-Octanoate Breath Test) | Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test. | 8 hour | 
| Gastric emptying rate (Magnetic resonance imaging) | Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging | Conditions B and C: 4 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiation | Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation). | 6 hour | 
| Safety profile VIPUN Balloon Catheter | Incidence, frequency, severity, seriousness and relatedness of AE's | Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks | 
| Feasibility VIPUN Balloon Catheter related procedures | Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter | Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks | 
| Reliability manual position check | Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter | Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0). | 
| Position catheter at t=480. | Qualitative assessment of the migration of the catheter over the course of the study procedures. | During Condition A only: at t=480 minutes (after cessation motility recording). | 
| Epigastric symptoms | Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric motility