xml: <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/NCT05962190</url>
    </required_header>
    <id_info>
      <org_study_id>211172</org_study_id>
      <nct_id>NCT05962190</nct_id>
    </id_info>
    <brief_title>Short-term Fat Overfeeding on the Effects of Liver Metabolism</brief_title>
    <acronym>FOS</acronym>
    <official_title>The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oxford</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically&#xD;
        deleterious, debate continues about whether there is a link between SFA and cardiovascular&#xD;
        disease risk. To explore this, we are undertaking a human in vivo parallel-design study,&#xD;
        comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with&#xD;
        unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on&#xD;
        postprandial metabolism, liver fat, cardiac fat and cardiac function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will recruit men and women with no medical condition or relevant drug&#xD;
        therapy that affects lipid, glucose or liver metabolism.&#xD;
  &#xD;
        Purpose and design:&#xD;
  &#xD;
        The investigators are asking the research question: &quot;How does the amount and type of fat&#xD;
        consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver&#xD;
        fat metabolism when someone is not gaining or losing body weight?&quot;&#xD;
  &#xD;
        To address this research question investigators want to undertake detail physiological&#xD;
        studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to&#xD;
        assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to&#xD;
        assess how their metabolic response to a experimental test meal, before and then 28 days&#xD;
        after consumption of a eucaloric, high fat intervention diet that will be either enriched in&#xD;
        saturated or unsaturated fat.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">February 2028</completion_date>
    <primary_completion_date type="Anticipated">February 2028</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Liver fat</measure>
      <time_frame>Pre- and after approx 28 days of consuming interventional diet</time_frame>
      <description>Changes in intrahepatic triglyceride, as measured by MRI</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postprandial plasma biochemistry</measure>
      <time_frame>Pre- and after approx 28 days of consuming interventional diet</time_frame>
      <description>Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Liver Fat</condition>
    <condition>Cardiac Function</condition>
    <condition>Lipid Disorder</condition>
    <condition>Adiposity</condition>
    <arm_group>
      <arm_group_label>High fat, high SFA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High fat, high UFA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Diet</intervention_name>
      <description>High fat (~60% of total energy intake) diet enriched with either SFA or UFA</description>
      <arm_group_label>High fat, high SFA</arm_group_label>
      <arm_group_label>High fat, high UFA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The participant is willing and able to give informed consent for participation in the&#xD;
               study.&#xD;
  &#xD;
            -  Male or Female, aged ≥18 or ≤65 years.&#xD;
  &#xD;
            -  Body Mass Index ≥19 ≤35 kg/m2&#xD;
  &#xD;
            -  No medical condition or relevant drug therapy that is known to affect liver or adipose&#xD;
               tissue metabolism.&#xD;
  &#xD;
            -  Weight stable for the previous 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The participant is unwilling or unable to give informed consent for participation in&#xD;
               the study. - Aged ≤18 or ≥65 years&#xD;
  &#xD;
            -  Body Mass Index ≤19 or ≥35kg/m2&#xD;
  &#xD;
            -  Blood haemoglobin &lt;135mg/dL for men and &lt;120mg/dL for women&#xD;
  &#xD;
            -  Donated (or lost) ≥250 ml of blood in the previous two months.&#xD;
  &#xD;
            -  On a weight loss diet or have decreased their body weight by &gt;5% in the previous 3&#xD;
               months.&#xD;
  &#xD;
            -  Have increased their body weight by &gt;5% in the previous 3 months.&#xD;
  &#xD;
            -  Any metabolic condition or relevant drug therapy&#xD;
  &#xD;
            -  Current smoker&#xD;
  &#xD;
            -  History of alcoholism or a greater than recommended alcohol intake (&gt;30 g of alcohol&#xD;
               daily for men and &gt;20 g of alcohol daily for women)&#xD;
  &#xD;
            -  Haemorrhagic disorders&#xD;
  &#xD;
            -  Anticoagulant treatment&#xD;
  &#xD;
            -  History of albumin allergy&#xD;
  &#xD;
            -  Pregnant or nursing mothers&#xD;
  &#xD;
            -  Women prescribed any contraceptive agent or device including oral contraceptives,&#xD;
               hormone replacement therapy (HRT) or who have used these within the last 12 months&#xD;
               History of severe claustrophobia&#xD;
  &#xD;
            -  Presence of metallic implants, pacemakers, or are unwilling to remove any piercings&#xD;
  &#xD;
            -  History of an eating disorder or any other psychological condition that may affect the&#xD;
               participant's ability to adhere to study intervention/experimental diets.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leanne Hodson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Oxford</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leanne Hodson</last_name>
      <phone>01865 857224</phone>
      <email>leanne.hodson@ocdem.ox.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Oxford Centre for Diabetes, Endocrinology and Metabolism</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 7LE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Leanne Hodson</last_name>
        <phone>01865 857224</phone>
        <email>leanne.hodson@ocdem.ox.ac.uk</email>
      </contact>
      <investigator>
        <last_name>Leanne Hodson, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lipid Metabolism Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962190
  org study id: 211172
  nct id: NCT05962190
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically
        deleterious, debate continues about whether there is a link between SFA and cardiovascular
        disease risk. To explore this, we are undertaking a human in vivo parallel-design study,
        comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with
        unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on
        postprandial metabolism, liver fat, cardiac fat and cardiac function.
  The investigators will recruit men and women with no medical condition or relevant drug
        therapy that affects lipid, glucose or liver metabolism.
  
        Purpose and design:
  
        The investigators are asking the research question: "How does the amount and type of fat
        consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver
        fat metabolism when someone is not gaining or losing body weight?"
  
        To address this research question investigators want to undertake detail physiological
        studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to
        assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to
        assess how their metabolic response to a experimental test meal, before and then 28 days
        after consumption of a eucaloric, high fat intervention diet that will be either enriched in
        saturated or unsaturated fat.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Liver fat
  time frame: Pre- and after approx 28 days of consuming interventional diet
  description: Changes in intrahepatic triglyceride, as measured by MRI
  measure: Postprandial plasma biochemistry
  time frame: Pre- and after approx 28 days of consuming interventional diet
  description: Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal
  arm group label: High fat, high SFA
  arm group type: Experimental
  description: ~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA
  arm group label: High fat, high UFA
  arm group type: Experimental
  description: ~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA
  intervention type: Behavioral
  intervention name: Diet
  description: High fat (~60% of total energy intake) diet enriched with either SFA or UFA
  arm group label: High fat, high SFA
  arm group label: High fat, high UFA
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Leanne Hodson, PhD
  role: Principal Investigator
  affiliation: University of Oxford
  last name: Leanne Hodson
  phone: 01865 857224
  email: leanne.hodson@ocdem.ox.ac.uk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Lipid Metabolism Disorders
  sharing ipd: No