NCT02226029

Brief 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. 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. 2.13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to their opposing binding affinity to water and fat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

August 25, 2014

Last Update Submit

April 8, 2015

Conditions

Healthy

Keywords

MRI, fat fraction, stomach, lipid emulsion

Outcome Measures

Primary Outcomes (1)

  • Fat fraction [%] of GI content

    up to 180 minutes

Secondary Outcomes (1)

  • Distal fat fraction [%]

    3, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes

Other Outcomes (1)

  • 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

Study Arms (2)

Lipid emulsion 1

EXPERIMENTAL

Rapeseed oil 20%, sucrose FAE P-1670 0.7%, water 79.3%

Other: Lipid emulsion

Lipid emulsion 2

EXPERIMENTAL

Rapeseed oil 20%, sodium stearoyl lactylate P45 veg 1.5%, water 78.5%

Other: Lipid emulsion

Interventions

Lipid emulsionOTHER

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

Lipid emulsion 1Lipid emulsion 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between age 18 and 50
  • BMI 18-25 kg/m²
  • Written informed consent

You may not qualify if:

  • History of GI, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse
  • Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
  • Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs
  • 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 or consumption of alcohol and drugs
  • Uncertainty about the willingness or ability of the participant to comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology and Hepatology, University Hopsital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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: 28566523DERIVED

MeSH Terms

Interventions

Fat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

EmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Andreas Steingötter, PhD

    University of Zurich

    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

August 25, 2014

First Posted

August 26, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

CH(1)