<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/NCT01669200</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12024</org_study_id>
    <nct_id>NCT01669200</nct_id>
  </id_info>
  <brief_title>Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment</brief_title>
  <official_title>Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to assess whether daily dosing with medium chain&#xD;
      triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit&#xD;
      followed by six post-baseline visits. The control and placebo groups will each be comprised&#xD;
      of ten subjects randomly assigned to the groups. The assessments at baseline will include&#xD;
      concomitant medications, vital signs, height, and weight. In addition, subjects will complete&#xD;
      a medical history questionnaire, and receive group instruction on incorporation of the study&#xD;
      products into the diet from a registered dietitian. Study products will be dispensed at each&#xD;
      visit in excess of requirements, and re-issued at every visit after measurement of the&#xD;
      remaining product that subjects will be instructed to bring to every visit. The post-baseline&#xD;
      study visits will include body weight and vital sign measurements, concomitant medications,&#xD;
      dispensation of study products, group instruction by a registered dietitian, and an&#xD;
      assessment for adverse events.&#xD;
&#xD;
      Between study visits the subjects will receive a telephone call from the study coordinator to&#xD;
      encourage compliance with the diet, and to ask about any adverse events. The study visits&#xD;
      will conclude at week 24. The psychological tests conducted by clinicians at screening will&#xD;
      be repeated during the cognitive testing visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in cognitive performance</measure>
    <time_frame>Assess in subjects at Baseline to week 24 using different Cognitive testing scores.</time_frame>
    <description>Daily dosing of in subjects with Medium Chain Triglyceride Oil will change cognition scores measured at baseline to the end of week 24 using cognitive testing results. (ADAS-Cog, Trails Making Test, Mini Mental State Exam, Digit Symbol Test and Short-Form 36 Health Survey).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Ketones</measure>
    <time_frame>Baselines to 6 months</time_frame>
    <description>A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Placebo Oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Chain Triglyceride Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medium Chain Triglyceride Oil</intervention_name>
    <description>Differential changes will be compared in the test group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.</description>
    <arm_group_label>Medium Chain Triglyceride Oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Oil</intervention_name>
    <description>Differential changes will be compared in the control group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.</description>
    <arm_group_label>Placebo Oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are male or female with a diagnosis of Mild Cognitive Impairment&#xD;
&#xD;
          2. Are 50 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Been on medication for Mild Cognitive Impairment less than 90 days&#xD;
&#xD;
          2. Major depression&#xD;
&#xD;
          3. Uncontrolled hypothyroidism&#xD;
&#xD;
          4. Known B12 deficiency&#xD;
&#xD;
          5. Hepatic (liver) disease or insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</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>Cognitive Dysfunction</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/NCT01669200
org study id: PBRC 12024
nct id: NCT01669200
lead sponsor: 
has dmc: No
The primary aim of this study is to assess whether daily dosing with medium chain
      triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive
      performance.
Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit
      followed by six post-baseline visits. The control and placebo groups will each be comprised
      of ten subjects randomly assigned to the groups. The assessments at baseline will include
      concomitant medications, vital signs, height, and weight. In addition, subjects will complete
      a medical history questionnaire, and receive group instruction on incorporation of the study
      products into the diet from a registered dietitian. Study products will be dispensed at each
      visit in excess of requirements, and re-issued at every visit after measurement of the
      remaining product that subjects will be instructed to bring to every visit. The post-baseline
      study visits will include body weight and vital sign measurements, concomitant medications,
      dispensation of study products, group instruction by a registered dietitian, and an
      assessment for adverse events.

      Between study visits the subjects will receive a telephone call from the study coordinator to
      encourage compliance with the diet, and to ask about any adverse events. The study visits
      will conclude at week 24. The psychological tests conducted by clinicians at screening will
      be repeated during the cognitive testing visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Improvement in cognitive performance
time frame: Assess in subjects at Baseline to week 24 using different Cognitive testing scores.
description: Daily dosing of in subjects with Medium Chain Triglyceride Oil will change cognition scores measured at baseline to the end of week 24 using cognitive testing results. (ADAS-Cog, Trails Making Test, Mini Mental State Exam, Digit Symbol Test and Short-Form 36 Health Survey).
measure: Serum Ketones
time frame: Baselines to 6 months
description: A blood test will compare results looking for an increase of Beta-Hydroxybutyrate in the blood.
arm group label: Placebo Oil
arm group type: Placebo Comparator
description: Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.
arm group label: Medium Chain Triglyceride Oil
arm group type: Experimental
description: Differential changes will be compared in the test group versus the control group at one month and six months with respect to BHB and insulin levels, and at six months with respect to cognitive scores.
intervention type: Other
intervention name: Medium Chain Triglyceride Oil
description: Differential changes will be compared in the test group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.
arm group label: Medium Chain Triglyceride Oil
intervention type: Other
intervention name: Placebo Oil
description: Differential changes will be compared in the control group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.
arm group label: Placebo Oil
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction