Enteral Nutrition Infusion Rate and Gastric Function
- Conditions
- Healthy
- Interventions
- Device: VIPUN Balloon Catheter
- Registration Number
- NCT03664570
- Lead Sponsor
- Prof Dr Jan Tack
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Condition B VIPUN Balloon Catheter * Infusion rate = 75 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Test Condition C VIPUN Balloon Catheter * Infusion rate = 250 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Testt Condition A VIPUN Balloon Catheter * Infusion rate = 25 ml/h * Radiography: confirmation balloon position * VIPUN Balloon Catheter * 13C-Octanoate Breath Test o
- Primary Outcome Measures
Name Time Method Motility 8 hour Motility index (MI) measured with the VIPUN Balloon Catheter.
Gastric emptying rate (13C-Octanoate Breath Test) 8 hour Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
Gastric emptying rate (Magnetic resonance imaging) Conditions B and C: 4 hour. Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Feasibility VIPUN Balloon Catheter related procedures Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter
Reliability manual position check 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). Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter
Safety profile VIPUN Balloon Catheter Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks Incidence, frequency, severity, seriousness and relatedness of AE's
Satiation 6 hour Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).
Position catheter at t=480. During Condition A only: at t=480 minutes (after cessation motility recording). Qualitative assessment of the migration of the catheter over the course of the study procedures.
Epigastric symptoms 6 hours 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.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium