<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/NCT03756779</url>
  </required_header>
  <id_info>
    <org_study_id>122016-032</org_study_id>
    <nct_id>NCT03756779</nct_id>
  </id_info>
  <brief_title>Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia</brief_title>
  <official_title>Randomized, Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</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>
      We are performing a pilot cross-over diet study involving 5 patients with heterozygous FH and&#xD;
      5 patients with unexplained ADH. The patients will be randomized to a low versus high&#xD;
      saturated fat diet for 4 weeks each. We hypothesize that patients with unexplained ADH may&#xD;
      have an exaggerated cholesterol response to saturated fat intake. The specific aim of this&#xD;
      study is to quantify the increase in LDL-C in unexplained ADH patients compared to FH&#xD;
      patients. The pilot study proposed here will develop preliminary data to be used for future&#xD;
      funding proposals of larger, randomized studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not enrolling subjects in the study.&#xD;
  </why_stopped>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LDL-cholesterol</measure>
    <time_frame>4 weeks</time_frame>
    <description>To quantify the change in low density lipoprotein cholesterol</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Familial Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Low Saturated Fat Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Goal will be to attain &lt;7% of daily calories from saturated fat. Replace it with energy from monounsaturated fat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Saturated Fat Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Goal will be to attain 15% of daily calories from saturated fat. Decrease intake of monounsaturated fat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>Dietary intervention with dietary modification of fat intake.</description>
    <arm_group_label>High Saturated Fat Diet</arm_group_label>
    <arm_group_label>Low Saturated Fat Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults, age &gt; 18 years or &lt; 80 years&#xD;
&#xD;
          2. Pre-treatment LDL-C greater than the 95th percentile for age and sex (corresponding to&#xD;
             190 mg/dL for most adults), with one of the 2 following criteria: (1) tendon xanthoma&#xD;
             (proband or first-degree relative) or (2) either first-degree relative with premature&#xD;
             CHD (age less than 55 years in men or 65 years in women) or pretreatment LDL-C greater&#xD;
             than the 95th percentile for age and sex.&#xD;
&#xD;
          3. Willing to come off medical therapy 4 weeks before and during study.&#xD;
&#xD;
          4. Willing to follow high/low saturated fat diet&#xD;
&#xD;
          5. Willing to attend dietary counseling sessions&#xD;
&#xD;
          6. Willing to attend frequent clinic visits&#xD;
&#xD;
          7. Subjects willing to participate under the conditions described in the informed consent&#xD;
             form (ICF) and able to sign the ICF and applicable HIPAA forms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of any clinically significant uncontrolled endocrine disease known to&#xD;
             influence serum lipids or lipoproteins. Note: patients on thyroid replacement therapy&#xD;
             can be included if the dosage of thyroxine has been stable for 6 weeks prior to the&#xD;
             first study visit and thyroid-stimulating hormone (TSH) level is within the normal&#xD;
             range.&#xD;
&#xD;
          2. Conditions of severe acute vascular stress (e.g. acute coronary syndrome, ischemic&#xD;
             stroke, or major vascular surgery) within 3 months prior to the first study visit.&#xD;
&#xD;
          3. Patients unable to maintain their current activity level or planning to increase their&#xD;
             activity level (e.g. new exercise regimen).&#xD;
&#xD;
          4. Pregnant or breast-feeding women.&#xD;
&#xD;
          5. Major illness&#xD;
&#xD;
          6. Secondary cause of dyslipidemia (e.g. obstructive liver disease, hypothyroidism, or&#xD;
             nephrotic syndrome)&#xD;
&#xD;
          7. Hospitalization within 3 months&#xD;
&#xD;
          8. Substance abuse (illegal drug use, chronic alcoholism or problematic use of alcohol or&#xD;
             total daily alcohol intake &gt;2 drinks per day in men and &gt; 1 drink per day in women).&#xD;
&#xD;
          9. Immunodeficiency or HIV-positive status&#xD;
&#xD;
         10. Illiteracy&#xD;
&#xD;
         11. Severe medical condition that may impair the ability of the person to participate in a&#xD;
             nutrition intervention study (e.g. digestive disease with fat intolerance, advanced&#xD;
             malignancy, or major neurological, psychiatric or endocrine disease)&#xD;
&#xD;
         12. Any other medical condition thought to limit survival to less than 1 year&#xD;
&#xD;
         13. Difficulties or major inconvenience to change dietary habits&#xD;
&#xD;
         14. History of food allergy with hypersensitivity to any of the components of olive oil or&#xD;
             nuts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diet study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03756779
org study id: 122016-032
nct id: NCT03756779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We are performing a pilot cross-over diet study involving 5 patients with heterozygous FH and
      5 patients with unexplained ADH. The patients will be randomized to a low versus high
      saturated fat diet for 4 weeks each. We hypothesize that patients with unexplained ADH may
      have an exaggerated cholesterol response to saturated fat intake. The specific aim of this
      study is to quantify the increase in LDL-C in unexplained ADH patients compared to FH
      patients. The pilot study proposed here will develop preliminary data to be used for future
      funding proposals of larger, randomized studies.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in LDL-cholesterol
time frame: 4 weeks
description: To quantify the change in low density lipoprotein cholesterol
arm group label: Low Saturated Fat Diet
arm group type: Experimental
description: Goal will be to attain <7% of daily calories from saturated fat. Replace it with energy from monounsaturated fat.
arm group label: High Saturated Fat Diet
arm group type: Active Comparator
description: Goal will be to attain 15% of daily calories from saturated fat. Decrease intake of monounsaturated fat.
intervention type: Other
intervention name: Dietary intervention
description: Dietary intervention with dietary modification of fat intake.
arm group label: High Saturated Fat Diet
arm group label: Low Saturated Fat Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperlipoproteinemia Type II
mesh term: Hypercholesterolemia
sharing ipd: No