<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/NCT03295448</url>
  </required_header>
  <id_info>
    <org_study_id>CARBIO</org_study_id>
    <nct_id>NCT03295448</nct_id>
  </id_info>
  <brief_title>Fatty Acid Biomarkers of Carbohydrate Intake</brief_title>
  <acronym>CARBIO</acronym>
  <official_title>Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</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 overall aim is to investigate if circulating fatty acids and lipids are influenced by&#xD;
      alterations in carbohydrate amount and quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this isocaloric clinical cross-over trial, the investigators aim to investigate if&#xD;
      circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and&#xD;
      quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality&#xD;
      (including sugar) influence circulating even-chain saturated fatty acids or if fatty&#xD;
      acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of&#xD;
      carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to&#xD;
      search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators&#xD;
      also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake&#xD;
      on lipoproteins, insulin sensitivity, inflammatory proteins.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Palmitic acid in different plasma fractions</measure>
    <time_frame>14-20 days</time_frame>
    <description>Measured by liquid gas chromatography (GC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids</measure>
    <time_frame>14-20 days</time_frame>
    <description>Measured by liquid GC</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Desaturation indices end lipogenic indices</measure>
    <time_frame>14-20 days</time_frame>
    <description>These indices are product-to-precursor fatty acids measured by GC</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Fat - Sugar - Fiber</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: consuming diets rich in fat, rich in sugar, and rich in fibers during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fat - Fiber - Sugar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: consuming diets rich in fat, rich in fiber, and rich sugar during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar - Fiber - Fat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Consuming diets rich in sugar, rich in fiber, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar - Fat - Fiber</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Consuming diets rich in sugar, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiber - Sugar - Fat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Consuming diets rich in fiber, rich in sugar, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiber - Fat - Sugar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: consuming diets rich in fiber, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low carbohydrate diet</intervention_name>
    <description>Diet low in carbohydrates (38%E), but higher in total and saturated fat.</description>
    <arm_group_label>Fat - Fiber - Sugar</arm_group_label>
    <arm_group_label>Fat - Sugar - Fiber</arm_group_label>
    <arm_group_label>Fiber - Fat - Sugar</arm_group_label>
    <arm_group_label>Fiber - Sugar - Fat</arm_group_label>
    <arm_group_label>Sugar - Fat - Fiber</arm_group_label>
    <arm_group_label>Sugar - Fiber - Fat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High carbohydrate, high sugar diet</intervention_name>
    <description>Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.</description>
    <arm_group_label>Fat - Fiber - Sugar</arm_group_label>
    <arm_group_label>Fat - Sugar - Fiber</arm_group_label>
    <arm_group_label>Fiber - Fat - Sugar</arm_group_label>
    <arm_group_label>Fiber - Sugar - Fat</arm_group_label>
    <arm_group_label>Sugar - Fat - Fiber</arm_group_label>
    <arm_group_label>Sugar - Fiber - Fat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High carbohydrate, low sugar diet</intervention_name>
    <description>Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.</description>
    <arm_group_label>Fat - Fiber - Sugar</arm_group_label>
    <arm_group_label>Fat - Sugar - Fiber</arm_group_label>
    <arm_group_label>Fiber - Fat - Sugar</arm_group_label>
    <arm_group_label>Fiber - Sugar - Fat</arm_group_label>
    <arm_group_label>Sugar - Fat - Fiber</arm_group_label>
    <arm_group_label>Sugar - Fiber - Fat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 20-38&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal lab tests (assessed by screening and judged by a physician), diabetes,&#xD;
             cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the&#xD;
             preceding 3 months of screening. Extreme diets, i.e. very-low carbohydrate diets,&#xD;
             intermittent fasting, vegan diets or allergic to gluten&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Riserus, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala univeristy hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fatty acids</keyword>
  <keyword>biomarker</keyword>
  <keyword>carbohydrate</keyword>
  <keyword>lipogenesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT03295448
org study id: CARBIO
nct id: NCT03295448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall aim is to investigate if circulating fatty acids and lipids are influenced by
      alterations in carbohydrate amount and quality.
In this isocaloric clinical cross-over trial, the investigators aim to investigate if
      circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and
      quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality
      (including sugar) influence circulating even-chain saturated fatty acids or if fatty
      acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of
      carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to
      search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators
      also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake
      on lipoproteins, insulin sensitivity, inflammatory proteins.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Palmitic acid in different plasma fractions
time frame: 14-20 days
description: Measured by liquid gas chromatography (GC)
measure: Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
time frame: 14-20 days
description: Measured by liquid GC
measure: Desaturation indices end lipogenic indices
time frame: 14-20 days
description: These indices are product-to-precursor fatty acids measured by GC
arm group label: Fat - Sugar - Fiber
arm group type: Active Comparator
description: Intervention: consuming diets rich in fat, rich in sugar, and rich in fibers during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
arm group label: Fat - Fiber - Sugar
arm group type: Active Comparator
description: Intervention: consuming diets rich in fat, rich in fiber, and rich sugar during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
arm group label: Sugar - Fiber - Fat
arm group type: Active Comparator
description: Intervention: Consuming diets rich in sugar, rich in fiber, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
arm group label: Sugar - Fat - Fiber
arm group type: Active Comparator
description: Intervention: Consuming diets rich in sugar, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
arm group label: Fiber - Sugar - Fat
arm group type: Active Comparator
description: Intervention: Consuming diets rich in fiber, rich in sugar, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
arm group label: Fiber - Fat - Sugar
arm group type: Active Comparator
description: Intervention: consuming diets rich in fiber, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
intervention type: Other
intervention name: Low carbohydrate diet
description: Diet low in carbohydrates (38%E), but higher in total and saturated fat.
arm group label: Fat - Fiber - Sugar
arm group label: Fat - Sugar - Fiber
arm group label: Fiber - Fat - Sugar
arm group label: Fiber - Sugar - Fat
arm group label: Sugar - Fat - Fiber
arm group label: Sugar - Fiber - Fat
intervention type: Other
intervention name: High carbohydrate, high sugar diet
description: Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
arm group label: Fat - Fiber - Sugar
arm group label: Fat - Sugar - Fiber
arm group label: Fiber - Fat - Sugar
arm group label: Fiber - Sugar - Fat
arm group label: Sugar - Fat - Fiber
arm group label: Sugar - Fiber - Fat
intervention type: Other
intervention name: High carbohydrate, low sugar diet
description: Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
arm group label: Fat - Fiber - Sugar
arm group label: Fat - Sugar - Fiber
arm group label: Fiber - Fat - Sugar
arm group label: Fiber - Sugar - Fat
arm group label: Sugar - Fat - Fiber
arm group label: Sugar - Fiber - Fat
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulf Riserus, PhD
role: Principal Investigator
affiliation: Uppsala University
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Dyslipidemias