<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/NCT02246933</url>
  </required_header>
  <id_info>
    <org_study_id>503815</org_study_id>
    <nct_id>NCT02246933</nct_id>
  </id_info>
  <brief_title>Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses</brief_title>
  <official_title>Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Georgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the&#xD;
      negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation&#xD;
      responses. Half of the participants will receive a high polyunsaturated fat diet )50%&#xD;
      carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty&#xD;
      acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the&#xD;
      other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%&#xD;
      carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated&#xD;
      fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total&#xD;
      energy will be saturated fatty acids.) for 7 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eating more saturated fats has been shown to decrease how many calories an individual burns&#xD;
      and increase chronic disease risk by increasing inflammation, coagulation (blood clotting)&#xD;
      potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has&#xD;
      been linked to decreased risk of chronic diseases. The goal of this study is to determine&#xD;
      whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the&#xD;
      damaging effects of eating occasional high-fat meals that are high in saturated fats. Those&#xD;
      damaging effects we are interested in studying include how much fat and calories a person's&#xD;
      body burns, and measuring some markers of chronic disease risk in the blood (inflammation&#xD;
      markers and blood clotting markers).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Blood Markers</measure>
    <time_frame>Change measures baseline and 9 days</time_frame>
    <description>Change in inflammation and coagulation factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Energy Expenditure</measure>
    <time_frame>Change measures baseline and 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Substrate Oxidation</measure>
    <time_frame>Change measures baseline and 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Blood Lipids</measure>
    <time_frame>Change measures baseline and 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>Change measures baseline and 9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Inflammation</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>PUFA Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PUFA Diet</intervention_name>
    <description>The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids.</description>
    <arm_group_label>PUFA Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Diet</intervention_name>
    <description>The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.</description>
    <arm_group_label>Control Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy men and women between the ages of 18 and 45y with a normal weight&#xD;
             based on body mass index (BMI=18-24.9kg/m2), must be sedentary (perform less than 3&#xD;
             hours per week of structured exercise) and , if participant has fasting total&#xD;
             cholesterol &gt;200 gm/dL, high-density lipoprotein &lt;40 mg/dL, low-density lipoprotein&#xD;
             cholesterol &gt;100 mg/dL, and/or triglycerides &gt;150 mg/dL (based on fasting blood&#xD;
             lipids).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss or gain exceeding 5% of body weight in the past 3 months&#xD;
&#xD;
          -  Current participation in a weight loss program&#xD;
&#xD;
          -  Any current exercisers (greater than 3h per week)&#xD;
&#xD;
          -  Any person who is on a medically prescribed diet&#xD;
&#xD;
          -  Any person who is vegan, or any type of vegetarian other than pesco-vegetarian&#xD;
&#xD;
          -  Any chronic or metabolic disease, hyperlipidemia, gastrointestinal disorder, or&#xD;
             history of medical or surgical events that could affect digestion and absorption of&#xD;
             nutrients&#xD;
&#xD;
          -  Any current supplement use other than a daily multivitamin (this includes fish oil&#xD;
             supplements)&#xD;
&#xD;
          -  Any current medication use other than birth control (this includes anti-inflammatory&#xD;
             NSAID use).&#xD;
&#xD;
          -  Anyone who is pregnant, lactating, or planning a pregnancy&#xD;
&#xD;
          -  Anyone who has donated blood or plasma in the last 20 days&#xD;
&#xD;
          -  Any tobacco users&#xD;
&#xD;
          -  Anyone who has allergies to the most common food allergens (milk, eggs, peanuts,&#xD;
             almonds, cashews, walnuts, fish, shellfish, soy and wheat) or to any of the food that&#xD;
             will provided during the study&#xD;
&#xD;
          -  Anyone who has allergies to any of the components of the liquid meals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jamie A Cooper, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Georgia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Georgia - Department of Foods and Nutrition</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>October 6, 2015</last_update_submitted>
  <last_update_submitted_qc>October 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Georgia</investigator_affiliation>
    <investigator_full_name>Jamie Cooper</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT02246933
org study id: 503815
nct id: NCT02246933
lead sponsor: 
has dmc: No
This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the
      negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation
      responses. Half of the participants will receive a high polyunsaturated fat diet )50%
      carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty
      acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the
      other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50%
      carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated
      fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total
      energy will be saturated fatty acids.) for 7 days.
Eating more saturated fats has been shown to decrease how many calories an individual burns
      and increase chronic disease risk by increasing inflammation, coagulation (blood clotting)
      potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has
      been linked to decreased risk of chronic diseases. The goal of this study is to determine
      whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the
      damaging effects of eating occasional high-fat meals that are high in saturated fats. Those
      damaging effects we are interested in studying include how much fat and calories a person's
      body burns, and measuring some markers of chronic disease risk in the blood (inflammation
      markers and blood clotting markers).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Blood Markers
time frame: Change measures baseline and 9 days
description: Change in inflammation and coagulation factors
measure: Change in Energy Expenditure
time frame: Change measures baseline and 9 days
measure: Change in Substrate Oxidation
time frame: Change measures baseline and 9 days
measure: Change in Fasting Blood Lipids
time frame: Change measures baseline and 9 days
measure: Change in Systolic Blood Pressure
time frame: Change measures baseline and 9 days
arm group label: PUFA Diet
arm group type: Experimental
arm group label: Control Diet
arm group type: Placebo Comparator
intervention type: Other
intervention name: PUFA Diet
description: The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids.
arm group label: PUFA Diet
intervention type: Other
intervention name: Control Diet
description: The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.
arm group label: Control Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jamie A Cooper, PhD
role: Principal Investigator
affiliation: University of Georgia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Georgia
investigator full name: Jamie Cooper
investigator title: Associate Professor
mesh term: Inflammation