NCT03410147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

January 18, 2018

Last Update Submit

July 18, 2018

Conditions

HealthyGastric Emptying

Outcome Measures

Primary Outcomes (1)

  • Hourly 13C-recovery

    Indicator for gastric emptying rate

    8 hour

Study Arms (3)

Concentration A

OTHER

Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml

Diagnostic Test: 13C-octanoate breath test for gastric emptying

Concentration B

OTHER

Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml

Diagnostic Test: 13C-octanoate breath test for gastric emptying

Concentration C

OTHER

Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml

Diagnostic Test: 13C-octanoate breath test for gastric emptying

Interventions

13C-octanoate breath test for gastric emptyingDIAGNOSTIC_TEST

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.

Concentration AConcentration BConcentration C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Gastric Emptying

Intervention Hierarchy (Ancestors)

Gastrointestinal MotilityDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A single blind, randomized, crossover monocentric study in a cohort of adult healthy volunteers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 25, 2018

Study Start

February 9, 2018

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

BE(1)