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

NCT02602158 | Completed Early Phase 1 DMC

• 1 other identifier: KEK-Nr. 2015-0450
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breath test; lipid emulsions; MRI; gastric emptying

Outcome Measures

Primary Outcomes (1)

• Half emptying time (T50) [min] as determined from 13CO2 recovery curves in breath using the exponential beta function

  upto 300 min

Secondary Outcomes (4)

• The T50 [min] of MRI fat volume emptying

  up to 180 min

• Correlation of MRI T50 [min] and breath test T50 [min

  up to 180 min (MRI) and every 10 min until 300 min (breath test)

• The maximum secretion volume [ml]

  up to 180 min

• Spatial heterogeneity of gastric content will be assessed using a variogram approach

  up to 180 min

Study Arms (2)

Octanoic acid (1-13C, 99%)

ACTIVE COMPARATOR

100 µL 13C Octanoic acid (Cambridge isotope laboratories)

Dietary Supplement: Octanoic acid (1-13C, 99%)

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

ACTIVE COMPARATOR

100 µL 13C Trioctanoin (Cambridge isotope laboratories)

Dietary Supplement: TRIOCTANOIN (1,1,1-13C3, 99%)

Interventions

Octanoic acid (1-13C, 99%) DIETARY_SUPPLEMENT

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

Octanoic acid (1-13C, 99%)

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

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18-25 kg/m²
• Written informed consent
• Years to 50 Years

You may not qualify if:

• History of GI, cardiorespiratory (including arterial
• hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes
• Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
• Requiring medication that might alter gut function, including calcium channel blockers, prokinetics, macrolide antibiotics
• Presence of metallic implants, devices or metallic foreign bodies
• Pregnancy and lactation (female participants of child bearing age will receive a pregnancy test prior to study)
• Claustrophobia
• Regular smoking
• A history of drug or alcohol abuse
• A history of food allergies or intolerances
• Uncertainty about the willingness or ability of the participant to comply with the protocol requirements

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hopsital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• Parker HL, Liu D, Curcic J, Ebert MO, Schwizer W, Fried M, Steingoetter A. Gastric and Postgastric Processing of 13C Markers Renders the 13C Breath Test an Inappropriate Measurement Method for the Gastric Emptying of Lipid Emulsions in Healthy Adults. J Nutr. 2017 Jul;147(7):1258-1266. doi: 10.3945/jn.117.248765. Epub 2017 May 31.

  PMID: 28566523 DERIVED

• Liu D, Parker HL, Curcic J, Kozerke S, Steingoetter A. Emulsion Stability Modulates Gastric Secretion and Its Mixing with Emulsified Fat in Healthy Adults in a Randomized Magnetic Resonance Imaging Study. J Nutr. 2016 Oct;146(10):2158-2164. doi: 10.3945/jn.116.234955. Epub 2016 Sep 7.

  PMID: 27605407 DERIVED

MeSH Terms

Interventions

octanoic acid; tricaprylin

Study Officials

• Andreas Steingötter, PhD

  Univeristy of Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 11, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 22, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)