<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02226029</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2014-0185</org_study_id>
    <secondary_id>SNF #146409</secondary_id>
    <nct_id>NCT02226029</nct_id>
  </id_info>
  <brief_title>Quantitative MR Methods for Lipid Emulsions</brief_title>
  <acronym>Q-MRemulsion</acronym>
  <official_title>Quantitative Magnetic Resonance (MR) Methods for Non-invasive Imaging of Gastro-intestinal (GI) Processing of Lipid Emulsions in Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quantitative MR methods will be validated for the non-invasive imaging of GI processing of&#xD;
      lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized single&#xD;
      blind two-armed crossover trial with two isovolumetric and isocaloric lipid emulsions of&#xD;
      different microstructural properties. Hypotheses of this sudy are that&#xD;
&#xD;
        1. the fat fraction of lipid emulsions in the GI tract can be monitored by quantitative MR&#xD;
           methods and that 13C-sodium octanoate and&#xD;
&#xD;
        2. 13C-sodium acetate in lipid emulsions will exhibit different excretion profiles due to&#xD;
           their opposing binding affinity to water and fat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be given two lipid emulsions with different physicochemical composition in&#xD;
      randomized order at two separate visits. A nasogastric tube will be applied for intragastric&#xD;
      lipid emulsion infusion to control for the effect of inter-individual tolerance to texture&#xD;
      and taste of the lipid emulsions. Standard MR measurements will be performed to regularly&#xD;
      assess intragastric fat content and related fat content emptying over a period of 3 hours. At&#xD;
      different pre-defined time points during gastric processing and emptying of the emulsions,&#xD;
      five samples of gastric content (5x2 ml) will be aspirated via the nasogastric tube to&#xD;
      determine local intragastric fat content with a density measurement. The measured fat&#xD;
      fraction of the aspirated samples will validate the non-invasive quantitative MR&#xD;
      measurements. Each participant will also undergo either a 13C-sodium acetate or a 13C-sodium&#xD;
      octanoate breath test at each of the two visits. Breath tests will be carried out throughout&#xD;
      the MR imagining period and for 2 hour post imaging. A subset of participants will undergo&#xD;
      the same breath test procedures but without the use of MR and gastric content samples.&#xD;
&#xD;
      2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and&#xD;
      shear stability. 13C-markers will be mixed with emulsions.&#xD;
&#xD;
        -  Lipid emulsion 1: acid stable, particle size 0.6 µm&#xD;
&#xD;
        -  Lipid emulsion 2: acid unstable, redispersible by mechanical processes during antral&#xD;
           contractions and passage through the pylorus, particle size 0.6 µm&#xD;
&#xD;
      Power calculation is based on an in-vitro pilot experiment, in which we determined a&#xD;
      variation in the detection of fat fraction in the lipid emulsions of 1.5%. With 12 enrolled&#xD;
      subjects, the detectable difference in fat fraction at a significance level of 0.05 and a&#xD;
      defined power of 0.9 is about 2%. In 18 enrolled subjects (12+6) that are separated into two&#xD;
      groups of 9, the detectable difference in 13CO2 recovery at a significance level of 0.05 and&#xD;
      a defined power of 0.9 is 0.15 Percent Dose Recovered per hr (PDR/hr).&#xD;
&#xD;
      This study will be conducted in compliance with the protocol, the current version of the&#xD;
      Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all&#xD;
      national legal and regulatory requirements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fat fraction [%] of GI content</measure>
    <time_frame>up to 180 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distal fat fraction [%]</measure>
    <time_frame>3, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>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</measure>
    <time_frame>every 10 minutes until 300 minutes</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lipid emulsion 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapeseed oil 20%, sucrose FAE P-1670 0.7%, water 79.3%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipid emulsion 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapeseed oil 20%, sodium stearoyl lactylate P45 veg 1.5%, water 78.5%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lipid emulsion</intervention_name>
    <description>2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability&#xD;
Lipid emulsion 1: acid stable, particle size 0.6 µm&#xD;
Lipid emulsion 2: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm&#xD;
13C-markers will be mixed with emulsions</description>
    <arm_group_label>Lipid emulsion 1</arm_group_label>
    <arm_group_label>Lipid emulsion 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between age 18 and 50&#xD;
&#xD;
          -  BMI 18-25 kg/m²&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of GI, cardiorespiratory (including arterial hypertension), hematologic,&#xD;
             renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or&#xD;
             alcohol abuse&#xD;
&#xD;
          -  Prior abdominal surgery other than uncomplicated appendectomy or hernia repair&#xD;
&#xD;
          -  Requiring medication that might alter gut function, including anticholinergics,&#xD;
             calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump&#xD;
             inhibitors, non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Presence of metallic implants, devices or metallic foreign bodies&#xD;
&#xD;
          -  Pregnancy and lactation (female participants of child bearing age will receive a&#xD;
             pregnancy test prior to study)&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Regular smoking or consumption of alcohol and drugs&#xD;
&#xD;
          -  Uncertainty about the willingness or ability of the participant to comply with the&#xD;
             protocol requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Steingötter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Gastroenterology and Hepatology, University Hopsital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI, fat fraction, stomach, lipid emulsion</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226029
org study id: KEK-ZH-Nr. 2014-0185
secondary id: SNF #146409
nct id: NCT02226029
lead sponsor: 
has dmc: Yes
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.
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.

        -  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

      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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Fat fraction [%] of GI content
time frame: up to 180 minutes
measure: Distal fat fraction [%]
time frame: 3, 10, 20, 30, 45, 60, 90, 120, 150 and 180 minutes
measure: 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
time frame: every 10 minutes until 300 minutes
arm group label: Lipid emulsion 1
arm group type: Experimental
description: Rapeseed oil 20%, sucrose FAE P-1670 0.7%, water 79.3%
arm group label: Lipid emulsion 2
arm group type: Experimental
description: Rapeseed oil 20%, sodium stearoyl lactylate P45 veg 1.5%, water 78.5%
intervention type: Other
intervention name: Lipid emulsion
description: 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
arm group label: Lipid emulsion 1
arm group label: Lipid emulsion 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Steingötter, PhD
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor