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| ID | Type | Description | Link |
|---|---|---|---|
| SNF #146409 | Other Grant/Funding Number | Swiss National Science Foundation |
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Quantitative MR methods will be validated for the non-invasive imaging of GI processing of lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized single blind two-armed crossover trial with two isovolumetric and isocaloric lipid emulsions of different microstructural properties. Hypotheses of this sudy are that
Participants will be given two lipid emulsions with different physicochemical composition in randomized order at two separate visits. A nasogastric tube will be applied for intragastric lipid emulsion infusion to control for the effect of inter-individual tolerance to texture and taste of the lipid emulsions. Standard MR measurements will be performed to regularly assess intragastric fat content and related fat content emptying over a period of 3 hours. At different pre-defined time points during gastric processing and emptying of the emulsions, five samples of gastric content (5x2 ml) will be aspirated via the nasogastric tube to determine local intragastric fat content with a density measurement. The measured fat fraction of the aspirated samples will validate the non-invasive quantitative MR measurements. Each participant will also undergo either a 13C-sodium acetate or a 13C-sodium octanoate breath test at each of the two visits. Breath tests will be carried out throughout the MR imagining period and for 2 hour post imaging. A subset of participants will undergo the same breath test procedures but without the use of MR and gastric content samples.
2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability. 13C-markers will be mixed with emulsions.
Power calculation is based on an in-vitro pilot experiment, in which we determined a variation in the detection of fat fraction in the lipid emulsions of 1.5%. With 12 enrolled subjects, the detectable difference in fat fraction at a significance level of 0.05 and a defined power of 0.9 is about 2%. In 18 enrolled subjects (12+6) that are separated into two groups of 9, the detectable difference in 13CO2 recovery at a significance level of 0.05 and a defined power of 0.9 is 0.15 Percent Dose Recovered per hr (PDR/hr).
This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipid emulsion 1 | Experimental | Rapeseed oil 20%, sucrose FAE P-1670 0.7%, water 79.3% |
|
| Lipid emulsion 2 | Experimental | Rapeseed oil 20%, sodium stearoyl lactylate P45 veg 1.5%, water 78.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid emulsion | Other | 2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat fraction [%] of GI content | up to 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Distal fat fraction [%] | 3, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters k and β from model B(t) = Dose*[β*(1- e(-k *t))(β-1) - (β- 1)*(1- e(-k *t))β] fitted to the 13C excretion profiles | every 10 minutes until 300 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Steingötter, PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology, University Hopsital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28566523 | Derived | 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. |
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| ID | Term |
|---|---|
| D005217 | Fat Emulsions, Intravenous |
| ID | Term |
|---|---|
| D004655 | Emulsions |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| D057947 |
| Parenteral Nutrition Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |