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/NCT05973539</url>
    </required_header>
    <id_info>
      <org_study_id>316098</org_study_id>
      <nct_id>NCT05973539</nct_id>
    </id_info>
    <brief_title>Blood Lipid Responses to Diet</brief_title>
    <acronym>BoLD</acronym>
    <official_title>Investigating Blood Lipid Responses to Dietary Macronutrient Content</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>No</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>
        The macronutrient composition of our diet (proportions of carbohydrates, fats and proteins)&#xD;
        strongly influences the way our body stores and utilises substrates (e.g., fats and sugars),&#xD;
        which in turn influences our risk of developing cardiometabolic diseases (e.g., coronary&#xD;
        artery disease or insulin resistance). The optimal dietary composition to lower the risk of&#xD;
        cardiometabolic disease is unknown.&#xD;
  &#xD;
        In a randomized, parallel design, this study will investigate how the overconsumption of&#xD;
        carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from&#xD;
        metabolic disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dietary and lifestyle interventions are central to lowering the risk and preventing the&#xD;
        development of metabolic disease, including non-alcoholic fatty liver disease, type 2&#xD;
        diabetes, and cardiovascular disease. There is, however, no one fits all dietary approach,&#xD;
        and in the context of diets where an individual is not gaining or losing weight (known as&#xD;
        eucaloric), the optimal macronutrient composition associated with a reduced risk of metabolic&#xD;
        disease and dyslipidemia is highly debated. For instance, eating less of one macronutrient&#xD;
        implies eating more of another; a reduction in the intake of dietary carbohydrates is met by&#xD;
        an increase in dietary fats. How this affects one's metabolic health in the setting when&#xD;
        someone is not gaining or losing body weight is unclear.&#xD;
  &#xD;
        Therefore, this study aims to provide an understanding of the effect that the quantity of&#xD;
        specific dietary macronutrients (e.g., carbohydrates, fats) have on plasma triglyceride&#xD;
        concentrations in both the fasting and postprandial state, liver fat content and metabolism,&#xD;
        and cardiac fat content and function.&#xD;
  &#xD;
        Sixty volunteers free from metabolic disease will be recruited into a randomized,&#xD;
        parallel-armed dietary intervention study. Participants will consume either a low&#xD;
        carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days. Diets&#xD;
        will be eucaloric (i.e., designed to meet the individual participant's energy requirements).&#xD;
        Comprehensive in vivo metabolic and physiological testing will be performed before and after&#xD;
        the experimental diet to document the effects of the overconsumption of specific&#xD;
        macronutrients (i.e., fats or carbohydrates) on liver and lipid metabolism.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">January 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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in plasma triglyceride concentrations [mmol/L]</measure>
      <time_frame>Pre- and post-diet [21-28 days]</time_frame>
      <description>Change in plasma triglyceride concentrations in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in liver fat content [%]</measure>
      <time_frame>Pre- and post-diet [21-28 days]</time_frame>
      <description>Liver fat content (intra-hepatic triglyceride) will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in cardiac fat content [%]</measure>
      <time_frame>Pre- and post-diet [21-28 days]</time_frame>
      <description>Cardiac fat content will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the contribution of dietary and adipose tissue derived fatty acids to very low density lipoprotein-triglyceride (VLDL-TG) palmitate</measure>
      <time_frame>Pre- and post-diet [21-28 days]</time_frame>
      <description>Through measuring the incorporation of [13C]palmitate and [2H2]palmitate in isolated plasma VLDL during a mixed-macronutrient feeding test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in hepatic fatty acid synthesis</measure>
      <time_frame>Pre- and post-diet [21-28 days]</time_frame>
      <description>Measured by incorporation of [2H2] palmitate from 2H2O into VLDL-triglyceride</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Nutritional and Metabolic Diseases</condition>
    <arm_group>
      <arm_group_label>High carbohydrate, low fat diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High fat, low carbohydrate diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diet</intervention_name>
      <description>Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)</description>
      <arm_group_label>High carbohydrate, low fat diet</arm_group_label>
      <arm_group_label>High fat, low carbohydrate diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is willing and able to give informed consent for participation in the&#xD;
               study.&#xD;
  &#xD;
            -  Male or Female, aged ≥18 to ≤65 years&#xD;
  &#xD;
            -  Body mass index (BMI) ≥19 to ≤35 kg/m2&#xD;
  &#xD;
            -  No medical condition or relevant drug therapy that is known to affect the liver,&#xD;
               adipose tissue, or cardiac metabolism.&#xD;
  &#xD;
            -  Weight stable for the previous 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged &lt;18 or &gt;65 years&#xD;
  &#xD;
            -  BMI &lt;19 or &gt;35 kg/m2&#xD;
  &#xD;
            -  A blood haemoglobin &lt;135 mg/dL for men and &lt;120 mg/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 decreased their body weight by &gt;5% in the previous 3 months&#xD;
  &#xD;
            -  Currently adhering to or have consumed in the previous 3 months a diet with a notably&#xD;
               altered macro-nutrient content (e.g. high-fat - low-carbohydrate diet)&#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;
            -  History of albumin allergy.&#xD;
  &#xD;
            -  Pregnant or nursing mothers&#xD;
  &#xD;
            -  History of severe claustrophobia&#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>Leane Hodson</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Oxford</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David J Dearlove</last_name>
      <phone>07739460623</phone>
      <email>david.dearlove@ocdem.ox.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leane Hodson</last_name>
      <email>leanne.hodson@ocdem.ox.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 7LE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Leanne Hodson, PhD</last_name>
        <phone>01865 857224</phone>
        <email>leanne.hodson@ocdem.ox.ac.uk</email>
      </contact>
    </location>
    <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>January 2023</verification_date>
    <study_first_submitted>January 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>Metabolic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to share IPD with other researchers</ipd_description>
    </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/NCT05973539
  org study id: 316098
  nct id: NCT05973539
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The macronutrient composition of our diet (proportions of carbohydrates, fats and proteins)
        strongly influences the way our body stores and utilises substrates (e.g., fats and sugars),
        which in turn influences our risk of developing cardiometabolic diseases (e.g., coronary
        artery disease or insulin resistance). The optimal dietary composition to lower the risk of
        cardiometabolic disease is unknown.
  
        In a randomized, parallel design, this study will investigate how the overconsumption of
        carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from
        metabolic disease.
  Dietary and lifestyle interventions are central to lowering the risk and preventing the
        development of metabolic disease, including non-alcoholic fatty liver disease, type 2
        diabetes, and cardiovascular disease. There is, however, no one fits all dietary approach,
        and in the context of diets where an individual is not gaining or losing weight (known as
        eucaloric), the optimal macronutrient composition associated with a reduced risk of metabolic
        disease and dyslipidemia is highly debated. For instance, eating less of one macronutrient
        implies eating more of another; a reduction in the intake of dietary carbohydrates is met by
        an increase in dietary fats. How this affects one's metabolic health in the setting when
        someone is not gaining or losing body weight is unclear.
  
        Therefore, this study aims to provide an understanding of the effect that the quantity of
        specific dietary macronutrients (e.g., carbohydrates, fats) have on plasma triglyceride
        concentrations in both the fasting and postprandial state, liver fat content and metabolism,
        and cardiac fat content and function.
  
        Sixty volunteers free from metabolic disease will be recruited into a randomized,
        parallel-armed dietary intervention study. Participants will consume either a low
        carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days. Diets
        will be eucaloric (i.e., designed to meet the individual participant's energy requirements).
        Comprehensive in vivo metabolic and physiological testing will be performed before and after
        the experimental diet to document the effects of the overconsumption of specific
        macronutrients (i.e., fats or carbohydrates) on liver and lipid metabolism.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Change in plasma triglyceride concentrations [mmol/L]
  time frame: Pre- and post-diet [21-28 days]
  description: Change in plasma triglyceride concentrations in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.
  measure: Change in liver fat content [%]
  time frame: Pre- and post-diet [21-28 days]
  description: Liver fat content (intra-hepatic triglyceride) will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy
  measure: Change in cardiac fat content [%]
  time frame: Pre- and post-diet [21-28 days]
  description: Cardiac fat content will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy
  measure: Change in the contribution of dietary and adipose tissue derived fatty acids to very low density lipoprotein-triglyceride (VLDL-TG) palmitate
  time frame: Pre- and post-diet [21-28 days]
  description: Through measuring the incorporation of [13C]palmitate and [2H2]palmitate in isolated plasma VLDL during a mixed-macronutrient feeding test.
  measure: Change in hepatic fatty acid synthesis
  time frame: Pre- and post-diet [21-28 days]
  description: Measured by incorporation of [2H2] palmitate from 2H2O into VLDL-triglyceride
  arm group label: High carbohydrate, low fat diet
  arm group type: Experimental
  description: 65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein.
  arm group label: High fat, low carbohydrate diet
  arm group type: Experimental
  description: 65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein.
  intervention type: Other
  intervention name: Diet
  description: Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
  arm group label: High carbohydrate, low fat diet
  arm group label: High fat, low carbohydrate diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Leane Hodson
  role: Principal Investigator
  affiliation: University of Oxford
  last name: David J Dearlove
  phone: 07739460623
  email: david.dearlove@ocdem.ox.ac.uk
  last name: Leane Hodson
  email: leanne.hodson@ocdem.ox.ac.uk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Metabolic Diseases
  sharing ipd: No
  ipd description: There are no plans to share IPD with other researchers