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Quantitative MR Methods for Lipid Emulsions

NCT02226029 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-04-09

No results posted yet for this study

Summary

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

1. the fat fraction of lipid emulsions in the GI tract can be monitored by quantitative MR methods and that 13C-sodium octanoate and
2. 13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to their opposing binding affinity to water and fat.

Conditions

  • Healthy

Interventions

OTHER

Lipid emulsion

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 * Lipid emulsion 2: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm * 13C-markers will be mixed with emulsions

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Andreas Steingötter, PhD · University of Zurich

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
2014-08-31
Primary Completion
2014-12-31
Completion
2015-03-31

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 NCT02226029 on ClinicalTrials.gov