<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/NCT01709643</url>
  </required_header>
  <id_info>
    <org_study_id>METC 12-3-025</org_study_id>
    <nct_id>NCT01709643</nct_id>
  </id_info>
  <brief_title>Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy</brief_title>
  <official_title>Postprandial Intrahepactic Lipid (IHL) and Intramyocellular Lipid (IMCL) Levels Measured With Proton Magnetic Resonance Spectroscopy (1H-MRS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Top Institute Food and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The major research objective is to assess the potential of Proton Magnetic Resonance&#xD;
      Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single&#xD;
      meal. Furthermore we aim to investigate whether the addition of protein to a high fat&#xD;
      breakfast results in a reduced postprandial accumulation of lipids when compared to a high&#xD;
      fat breakfast alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fat accumulation in non-adipose tissue, such as liver and muscle, is associated with reduced&#xD;
      insulin sensitivity and cardiovascular disease. Little is known about the dietary&#xD;
      determinants and the time course of this ectopic fat accumulation. Therefore the general aim&#xD;
      of this project is to develop and validate methodology to follow postprandial hepatic and&#xD;
      muscular lipid retention. Proton Magnetic Resonance Spectroscopy (1H-MRS) is a&#xD;
      well-established tool for noninvasive quantification of intrahepatic lipids (IHL) and&#xD;
      intramyocellular lipids (IMCL). Previous studies have suggested a relatively rapid regulation&#xD;
      of IHL and IMCL levels, indicated by changes in these total lipid pools after high fat diets&#xD;
      of 3 or 4 days. Although IHL and IMCL levels seem to change rapidly, data on IHL and IMCL&#xD;
      levels after a single meal are lacking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between pre- and postprandial IHL and IMCL</measure>
    <time_frame>3 and 5 hours after high fat breakfast</time_frame>
    <description>The primary research objective is to assess the potential of 1H-MRS to follow IHL and IMCL dynamics after a single meal in lean and obese subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast</measure>
    <time_frame>3 and 5 hours after high fat breakfast</time_frame>
    <description>We aim to investigate whether the addition of protein to a high fat breakfast (HFP) results in a reduced postprandial accumulation of lipids when compared to a high fat breakfast (HF) alone.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fat and fat free mass of subjects</measure>
    <time_frame>One week before the first MR measurements</time_frame>
    <description>Body composition of the subjects is measured with underwaterweighing method</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood plasma insulin levels</measure>
    <time_frame>Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood plasma glucose levels</measure>
    <time_frame>Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood plasma free fatty acid level</measure>
    <time_frame>Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood plasma triglyceride level</measure>
    <time_frame>Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Postprandial IHL and IMCL Dynamics</condition>
  <arm_group>
    <arm_group_label>High fat breakfast lean subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High fat breakfast,obese subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HF breakfast with protein,lean subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HF breakfast with protein,obese subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High fat breakfast</intervention_name>
    <description>The HF breakfast will consist of sausage rolls (&quot;saucijzenbroodjes&quot;), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).</description>
    <arm_group_label>High fat breakfast lean subjects</arm_group_label>
    <arm_group_label>High fat breakfast,obese subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>HF breakfast with protein</intervention_name>
    <description>For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.</description>
    <arm_group_label>HF breakfast with protein,lean subjects</arm_group_label>
    <arm_group_label>HF breakfast with protein,obese subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Stable dietary habits&#xD;
&#xD;
          -  No use of medication&#xD;
&#xD;
          -  Lean subjects: BMI 18-25 kg/m2&#xD;
&#xD;
          -  Obese subjects: BMI 30-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition requiring treatment and/or medication use&#xD;
&#xD;
          -  Alcohol consumption of more than 20 g per day (± 2 units)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Unstable body weight (weight gain or loss &gt; 3 kg in the past three months)&#xD;
&#xD;
          -  Participation in another biomedical study within 1 month prior to the screening visit&#xD;
&#xD;
          -  Contraindications for MRI scan:&#xD;
&#xD;
               -  Central nervous system aneurysm clips&#xD;
&#xD;
               -  Implanted neural stimulator&#xD;
&#xD;
               -  Implanted cardiac pacemaker of defibrillator&#xD;
&#xD;
               -  Cochlear implant&#xD;
&#xD;
               -  Iron- containing corpora aliena in the eye or brain&#xD;
&#xD;
               -  Hearing aids and artificial (heart) valves which is contraindicated for MRS&#xD;
&#xD;
               -  Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maastricht University Medical Center +</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>September 19, 2016</last_update_submitted>
  <last_update_submitted_qc>September 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01709643
org study id: METC 12-3-025
nct id: NCT01709643
lead sponsor: 
collaborator: 
has dmc: No
The major research objective is to assess the potential of Proton Magnetic Resonance
      Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single
      meal. Furthermore we aim to investigate whether the addition of protein to a high fat
      breakfast results in a reduced postprandial accumulation of lipids when compared to a high
      fat breakfast alone.
Fat accumulation in non-adipose tissue, such as liver and muscle, is associated with reduced
      insulin sensitivity and cardiovascular disease. Little is known about the dietary
      determinants and the time course of this ectopic fat accumulation. Therefore the general aim
      of this project is to develop and validate methodology to follow postprandial hepatic and
      muscular lipid retention. Proton Magnetic Resonance Spectroscopy (1H-MRS) is a
      well-established tool for noninvasive quantification of intrahepatic lipids (IHL) and
      intramyocellular lipids (IMCL). Previous studies have suggested a relatively rapid regulation
      of IHL and IMCL levels, indicated by changes in these total lipid pools after high fat diets
      of 3 or 4 days. Although IHL and IMCL levels seem to change rapidly, data on IHL and IMCL
      levels after a single meal are lacking.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Difference between pre- and postprandial IHL and IMCL
time frame: 3 and 5 hours after high fat breakfast
description: The primary research objective is to assess the potential of 1H-MRS to follow IHL and IMCL dynamics after a single meal in lean and obese subjects.
measure: Difference between postprandial IHL and IMCL in high fat and high fat with extra protein breakfast
time frame: 3 and 5 hours after high fat breakfast
description: We aim to investigate whether the addition of protein to a high fat breakfast (HFP) results in a reduced postprandial accumulation of lipids when compared to a high fat breakfast (HF) alone.
measure: Fat and fat free mass of subjects
time frame: One week before the first MR measurements
description: Body composition of the subjects is measured with underwaterweighing method
measure: Blood plasma insulin levels
time frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma glucose levels
time frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma free fatty acid level
time frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
measure: Blood plasma triglyceride level
time frame: Ten minutes prior to high fat breakfast and 0.5, 1,2,3.5,4.5,5.5 hours after the high fat breakfast
arm group label: High fat breakfast lean subjects
arm group type: Other
description: Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).
arm group label: High fat breakfast,obese subjects
arm group type: Other
description: Subjects will consume a high fat breakfast, containing of sausage rolls. Energy content of the breakfast will be set to 50 % of the recommended daily calorie intake (BMR times 1.3).
arm group label: HF breakfast with protein,lean subjects
arm group type: Other
description: For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,
arm group label: HF breakfast with protein,obese subjects
arm group type: Other
description: For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls. The amount of added proteins will be calculated to assure that the total energy content from proteins in the breakfast equals 20 %,
intervention type: Dietary Supplement
intervention name: High fat breakfast
description: The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).
arm group label: High fat breakfast lean subjects
arm group label: High fat breakfast,obese subjects
intervention type: Dietary Supplement
intervention name: HF breakfast with protein
description: For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
arm group label: HF breakfast with protein,lean subjects
arm group label: HF breakfast with protein,obese subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor