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13C Trioctanoate Breath Test as a Measurement of Gastric Fat Volume Emptying

NCT02602158 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-07-22

No results posted yet for this study

Summary

13C breath tests represent an attractive alternative in the measurement of gastric emptying (GE). Therefore these tests have been used in a variety of clinical settings such as in the assessment of gastroparesis, delayed GE in diabetic patients or in the assessment of GE with fat containing enteral formulas in critically ill patients.

The investigators have previously demonstrated that the 13C sodium octanoate breath test (OBT) is an inappropriate measurement method for the GE of fat. The OBT appears to be affected by 1) post gastric processing of the OCC marker and 2) its interaction with the physical form and concentration of the fat present in the stomach and duodenum.

The13C trioctanoate breath test (TriOBT) represents an attractive alternative to the OBT. Compared to OCC which is a medium chain fatty acid the 13C trioctanoate (TriOCC) is a triglyceride. TriOCC has similar physio chemical properties as the nutritional lipid e.g. rapeseed oil.

This study aims to assess the efficacy of the TriOBT as a GE measurement method of fat in an acid stable lipid emulsion (LE1). The breath test results from the TriOBT will be compared with the OBT and further validated against gastric fat volume emptying data observed from MRI. The interim analysis will determine whether the study will proceed to stage 2 which will assess the efficacy of the TriOBT in an acid unstable lipid emulsion (LE4).

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Octanoic acid (1-13C, 99%)

13C-marker will be mixed with emulsions. 2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability Lipid emulsion 1: acid stable, particle size 0.6 µm Optional study pending interim analysis: Lipid emulsion 4: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm

DIETARY_SUPPLEMENT

TRIOCTANOIN (1,1,1-13C3, 99%)

13C-marker will be mixed with emulsions 2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability Lipid emulsion 1: acid stable, particle size 0.6 µm Optional study pending interim analysis: Lipid emulsion 4: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Andreas Steingötter, PhD · Univeristy of Zürich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02602158 on ClinicalTrials.gov