HealthyEarly Phase 113CTriOBTNCT02602158
13C Trioctanoate Breath Test as a Measurement of Gastric Fat Volume Emptying
A Early Phase 1 study testing Octanoic acid (1-13C, 99%) and TRIOCTANOIN (1,1,1-13C3, 99%) in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Octanoic acid (1-13C, 99%) and TRIOCTANOIN (1,1,1-13C3, 99%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Apr 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25 kg/m²
- Written informed consent
- 18 Years to 50 Years
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The13C Trioctanoate Breath Test as a Measurement Method for the Gastric Emptying of Fat; a Randomised, Single Blinded, Cross Over Study
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.
Read more
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).
Read the detailed description
13C breath tests for the measurement of gastric emptying (GE) were first developed in the early 1990s. These tests have clear advantages over many other GE imaging techniques as they are relatively inexpensive, simple to use, can be carried out in children and pregnant women or those who have contraindications to MRI. Therefore these tests have been used in a variety of clinical settings such as in the assessment of gastroparesis or delayed GE in diabetic patients or the assessment of GE with fat containing enteral formulas in critically ill patients. Breath tests rely upon the ingestion of a 13C stable isotope markers such as the medium chain fatty acid 13C octanoic acid (OCC) and the tryglyceride13C trioctanoate (TriOCC).
However, 13C breath tests are an indirect measure of GE. Thus, GE data acquired from breath tests are a result of numerous complex interactions which include: 1) the chemical properties of markers and their interactions with test meals during gastric processing 2) absorption from the duodenum, 3) metabolism by the liver (oxidation of fatty acids) and 4) final excretion as 13CO2 by the lungs. All of these complex interactions can become compounded when the gastric processing of lipid emulsions (LEs) are investigated and thus careful consideration and selection of breath test markers is required.
The investigators have developed isocaloric and isovolume LEs with different GE properties as shown previously with MRI. The acid stable (LE1) and acid unstable lipid emulsion (LE4) responds differently to the conditions within the stomach. LE1 empties relatively uniformly from the stomach. However, the LE4 separates into water and high fat phases after 15-30 min of being in the stomach. In the late phase of GE the emulsion is re-emulsified and thus there are three distinct GE phases in LE4. Once separation of LE4 occurs the aqueous and low fat phase empties fairly rapidly from the stomach whereas the second fat phase empties more slowly. The differing GE pattern of acid unstable LEs has a profound effect on GE breath test data dependent upon the selection of the breath test marker used.The investigators have previously demonstrated that the OCC breath test (OBT) is an inappropriate measure of the gastric emptying of fat as the OBT is influenced 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. These effects were highlighted by only a marginal concordance agreement with the OBT half emptying (T50) of 13CO2 recovery and fat volume T50 (MRI T50) with LE1 and no agreement with LE4 (rc=0.7 and rc=0.4 respectively)..
The main aim of this study is to investigate whether TriOCC is a more appropriate breath test marker to use in the measurement of the GE of fat. As the TriOCC is a triglyceride it has similar physiochemical properties to nutritional lipids. Therefore, it is more likely to behave similarly in the gastric and duodenal environment to ingested lipids in emulsions such as rapeseed oil. In study 1 the investigators will compare the breath test markers TriOCC and OCC in LE1. In a sub set of participants a validated MRI quantitative fat fraction method will be used to determine reference values for the half gastric emptying time of fat (MRI T50). This will be correlated to half emptying (T50) of 13CO2 recovery generated from percentage dose recovery per hour (PDR/h) curves. The interim analysis will assess whether the TriOCC is more related to gastric fat volume emptying than the OCC marker in LE1. Should TriOCC be representative of gastric fat volume emptying study 2 will then proceed. Study 2 will then assess the gastric emptying of fat as above but with LE4.
A secondary aim is to develop an algorithm to quantify the heterogeneity of fat distribution within gastric content for MRI data. The gastric processing of lipid emulsions as visualized by MRI has been shown to result in a large inter individual variation of fat distribution. By quantifying this heterogeneity we aim to determine the degree of flocculation and creaming of the emulsions across the length of the stomach.
- Conditions
- Healthy
- Being tested
- Octanoic acid (1-13C, 99%), TRIOCTANOIN (1,1,1-13C3, 99%)
- Keywords
- breath test, lipid emulsions, MRI, gastric emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Octanoic acid (1-13C, 99%) | Active comparator | 100 µL 13C Octanoic acid (Cambridge isotope laboratories) Receives: Dietary Supplement: Octanoic acid (1-13C, 99%) |
| TRIOCTANOIN (1,1,1-13C3, 99%) | Active comparator | 100 µL 13C Trioctanoin (Cambridge isotope laboratories) Receives: Dietary Supplement: TRIOCTANOIN (1,1,1-13C3, 99%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half emptying time (T50) [min] as determined from 13CO2 recovery curves in breath using the exponential beta function
Measured: upto 300 min
Secondary outcomes (4)
The T50 [min] of MRI fat volume emptying
Measured: up to 180 min
Correlation of MRI T50 [min] and breath test T50 [min
Measured: up to 180 min (MRI) and every 10 min until 300 min (breath test)
The maximum secretion volume [ml]
Measured: up to 180 min
Spatial heterogeneity of gastric content will be assessed using a variogram approach
Measured: up to 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Steingötter, PhD, Principal investigator, Univeristy of Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602158
- Sponsor's protocol ID
- KEK-Nr. 2015-0450
- Acronym
- 13CTriOBT
- Status last verified
- Jul 2016
- First submitted
- 28 Oct 2015
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28566523Liu 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.
PubMed 27605407
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The13C Trioctanoate Breath Test as a Measurement Method for the Gastric Emptying of Fat; a Randomised, Single Blinded, Cross Over Study
- ClinicalTrials.gov ID
- NCT02602158
- Acronym / sponsor ID
- 13CTriOBT / KEK-Nr. 2015-0450
- Conditions
- Healthy
- Keywords
- breath test, lipid emulsions, MRI, gastric emptying
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
13C breath tests for the measurement of gastric emptying (GE) were first developed in the early 1990s. These tests have clear advantages over many other GE imaging techniques as they are relatively inexpensive, simple to use, can be carried out in children and pregnant women or those who have contraindications to MRI. Therefore these tests have been used in a variety of clinical settings such as in the assessment of gastroparesis or delayed GE in diabetic patients or the assessment of GE with fat containing enteral formulas in critically ill patients. Breath tests rely upon the ingestion of a 13C stable isotope markers such as the medium chain fatty acid 13C octanoic acid (OCC) and the tryglyceride13C trioctanoate (TriOCC).
However, 13C breath tests are an indirect measure of GE. Thus, GE data acquired from breath tests are a result of numerous complex interactions which include: 1) the chemical properties of markers and their interactions with test meals during gastric processing 2) absorption from the duodenum, 3) metabolism by the liver (oxidation of fatty acids) and 4) final excretion as 13CO2 by the lungs. All of these complex interactions can become compounded when the gastric processing of lipid emulsions (LEs) are investigated and thus careful consideration and selection of breath test markers is required.
The investigators have developed isocaloric and isovolume LEs with different GE properties as shown previously with MRI. The acid stable (LE1) and acid unstable lipid emulsion (LE4) responds differently to the conditions within the stomach. LE1 empties relatively uniformly from the stomach. However, the LE4 separates into water and high fat phases after 15-30 min of being in the stomach. In the late phase of GE the emulsion is re-emulsified and thus there are three distinct GE phases in LE4. Once separation of LE4 occurs the aqueous and low fat phase empties fairly rapidly from the stomach whereas the second fat phase empties more slowly. The differing GE pattern of acid unstable LEs has a profound effect on GE breath test data dependent upon the selection of the breath test marker used.The investigators have previously demonstrated that the OCC breath test (OBT) is an inappropriate measure of the gastric emptying of fat as the OBT is influenced 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. These effects were highlighted by only a marginal concordance agreement with the OBT half emptying (T50) of 13CO2 recovery and fat volume T50 (MRI T50) with LE1 and no agreement with LE4 (rc=0.7 and rc=0.4 respectively)..
The main aim of this study is to investigate whether TriOCC is a more appropriate breath test marker to use in the measurement of the GE of fat. As the TriOCC is a triglyceride it has similar physiochemical properties to nutritional lipids. Therefore, it is more likely to behave similarly in the gastric and duodenal environment to ingested lipids in emulsions such as rapeseed oil. In study 1 the investigators will compare the breath test markers TriOCC and OCC in LE1. In a sub set of participants a validated MRI quantitative fat fraction method will be used to determine reference values for the half gastric emptying time of fat (MRI T50). This will be correlated to half emptying (T50) of 13CO2 recovery generated from percentage dose recovery per hour (PDR/h) curves. The interim analysis will assess whether the TriOCC is more related to gastric fat volume emptying than the OCC marker in LE1. Should TriOCC be representative of gastric fat volume emptying study 2 will then proceed. Study 2 will then assess the gastric emptying of fat as above but with LE4.
A secondary aim is to develop an algorithm to quantify the heterogeneity of fat distribution within gastric content for MRI data. The gastric processing of lipid emulsions as visualized by MRI has been shown to result in a large inter individual variation of fat distribution. By quantifying this heterogeneity we aim to determine the degree of flocculation and creaming of the emulsions across the length of the stomach.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octanoic acid (1-13C, 99%) | Active comparator | Dietary Supplement: Octanoic acid (1-13C, 99%)100 µL 13C Octanoic acid (Cambridge isotope laboratories) |
| TRIOCTANOIN (1,1,1-13C3, 99%) | Active comparator | Dietary Supplement: TRIOCTANOIN (1,1,1-13C3, 99%)100 µL 13C Trioctanoin (Cambridge isotope laboratories) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18-25 kg/m²
- Written informed consent
- 18 Years to 50 Years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Octanoic acid (1-13C, 99%) |
| 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 | Dietary supplement | TRIOCTANOIN (1,1,1-13C3, 99%) |
Primary outcome
Half emptying time (T50) [min] as determined from 13CO2 recovery curves in breath using the exponential beta function
Time frame: upto 300 min
4 secondary outcomes
The T50 [min] of MRI fat volume emptying
Time frame: up to 180 min
Correlation of MRI T50 [min] and breath test T50 [min
Time frame: up to 180 min (MRI) and every 10 min until 300 min (breath test)
The maximum secretion volume [ml]
Time frame: up to 180 min
Spatial heterogeneity of gastric content will be assessed using a variogram approach
Time frame: up to 180 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Derived from this study: PubMed 28566523Parker 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.
- Derived from this study: PubMed 27605407Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Steingötter, PhD principal investigator
Univeristy of Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Octanoic acid (1-13C, 99%) and TRIOCTANOIN (1,1,1-13C3, 99%) in people with Healthy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half emptying time (T50) [min] as determined from 13CO2 recovery curves in breath using the exponential beta function (time frame: upto 300 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.