<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/NCT02211612</url>
  </required_header>
  <id_info>
    <org_study_id>LIPOGAIN-2</org_study_id>
    <nct_id>NCT02211612</nct_id>
  </id_info>
  <brief_title>Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation</brief_title>
  <acronym>LIPOGAIN-2</acronym>
  <official_title>Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate metabolic and molecular response to fatty acid-specific overfeeding in&#xD;
      overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin&#xD;
      sensitivity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in lean tissue mass</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hepatic fat content</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visceral adipose tissue (VAT)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total adipose tissue</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by magnetic resonance imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pancreatic fat</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessed by oral glucose tolerance test (OGTT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma lipids</measure>
    <time_frame>10 weeks</time_frame>
    <description>Plasma cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoprotein B, apolipoprotein A1, free fatty acids, glycerol, proprotein convertase subtilisin/kexin type 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circulating inflammation and coagulation markers</measure>
    <time_frame>10 weeks</time_frame>
    <description>Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Circulating hormones and molecular analyses in muscle and fat tissue</measure>
    <time_frame>10 weeks</time_frame>
    <description>Serum hormones including prolactin, tyroxin, T3, cortisol, growth hormone, Insulin growth factor-1. Fat cell morphology assessment in fat tissue, and gene and protein expression, DNA methylation analyses in fat and muscle tissue, palmitate tracer uptake in liver using positron emission tomography</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <condition>Overfeeding</condition>
  <condition>Muscle Mass</condition>
  <condition>Body Composition</condition>
  <condition>Ectopic Fat</condition>
  <arm_group>
    <arm_group_label>Saturated fatty acids (SFA)-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight gain created by addition of muffins baked on saturated fat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyunsaturated fatty acids (PUFA)-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight gain created by addition of muffins baked on polyunsaturated fat</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PUFA-group</intervention_name>
    <arm_group_label>Polyunsaturated fatty acids (PUFA)-group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SFA-group</intervention_name>
    <arm_group_label>Saturated fatty acids (SFA)-group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index 25-32&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Abnormal clinical chemistry at screening&#xD;
&#xD;
          -  Intense physical exercise &gt; 2 hours per week&#xD;
&#xD;
          -  Use of statins or drugs affecting energy metabolism&#xD;
&#xD;
          -  Use of extreme diets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Riserus</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences</name>
      <address>
        <city>Uppsala</city>
        <state>Please Select</state>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University</investigator_affiliation>
    <investigator_full_name>David Iggman</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Overfeeding</keyword>
  <keyword>Weight gain</keyword>
  <keyword>Liver fat</keyword>
  <keyword>Pancreatic fat</keyword>
  <keyword>Ectopic fat</keyword>
  <keyword>Skeletal muscle</keyword>
  <keyword>Adipose tissue</keyword>
  <keyword>Gene expression</keyword>
  <keyword>DNA methylation</keyword>
  <keyword>Palmitate</keyword>
  <keyword>Linoleic acid</keyword>
  <keyword>Saturated fat</keyword>
  <keyword>Polyunsaturated fat</keyword>
  <keyword>Metabolism</keyword>
  <keyword>Insulin sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiac Complexes, Premature</mesh_term>
  </condition_browse>
  <!-- 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/NCT02211612
org study id: LIPOGAIN-2
nct id: NCT02211612
lead sponsor: 
collaborator: 
has dmc: No
To investigate metabolic and molecular response to fatty acid-specific overfeeding in
      overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin
      sensitivity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in lean tissue mass
time frame: 10 weeks
description: Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)
measure: Change in hepatic fat content
time frame: 10 weeks
description: Assessed by magnetic resonance imaging (MRI)
measure: Change in visceral adipose tissue (VAT)
time frame: 10 weeks
description: Assessed by magnetic resonance imaging (MRI)
measure: Change in total adipose tissue
time frame: 10 weeks
description: Assessed by magnetic resonance imaging (MRI)
measure: Change in pancreatic fat
time frame: 10 weeks
description: Assessed by MRI
measure: Change in insulin sensitivity
time frame: 10 weeks
description: Assessed by oral glucose tolerance test (OGTT)
measure: Change in plasma lipids
time frame: 10 weeks
description: Plasma cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoprotein B, apolipoprotein A1, free fatty acids, glycerol, proprotein convertase subtilisin/kexin type 9
measure: Change in circulating inflammation and coagulation markers
time frame: 10 weeks
description: Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules
measure: Circulating hormones and molecular analyses in muscle and fat tissue
time frame: 10 weeks
description: Serum hormones including prolactin, tyroxin, T3, cortisol, growth hormone, Insulin growth factor-1. Fat cell morphology assessment in fat tissue, and gene and protein expression, DNA methylation analyses in fat and muscle tissue, palmitate tracer uptake in liver using positron emission tomography
arm group label: Saturated fatty acids (SFA)-group
arm group type: Experimental
description: Weight gain created by addition of muffins baked on saturated fat
arm group label: Polyunsaturated fatty acids (PUFA)-group
arm group type: Experimental
description: Weight gain created by addition of muffins baked on polyunsaturated fat
intervention type: Dietary Supplement
intervention name: PUFA-group
arm group label: Polyunsaturated fatty acids (PUFA)-group
intervention type: Dietary Supplement
intervention name: SFA-group
arm group label: Saturated fatty acids (SFA)-group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulf Riserus
role: Principal Investigator
affiliation: Uppsala University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Uppsala University
investigator full name: David Iggman
investigator title: MD
mesh term: Cardiac Complexes, Premature