Clinical trial NCT03664570: Enteral Nutrition Infusion Rate and Gastric Function
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gastric motility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-way crossover
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Motility
timeFrame: 8 hour
measure: Gastric emptying rate (13C-Octanoate Breath Test)
timeFrame: 8 hour
measure: Gastric emptying rate (Magnetic resonance imaging)
timeFrame: Conditions B and C: 4 hour.
Secondary outcomes:
measure: Satiation
timeFrame: 6 hour
measure: Safety profile VIPUN Balloon Catheter
timeFrame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
measure: Feasibility VIPUN Balloon Catheter related procedures
timeFrame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
measure: Reliability manual position check
timeFrame: 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).
measure: Position catheter at t=480.
timeFrame: During Condition A only: at t=480 minutes (after cessation motility recording).
measure: Epigastric symptoms
timeFrame: 6 hours
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References: