<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/NCT02245035</url>
  </required_header>
  <id_info>
    <org_study_id>12884</org_study_id>
    <nct_id>NCT02245035</nct_id>
  </id_info>
  <brief_title>Dairy Intake and Brain Health in Aging</brief_title>
  <official_title>Dairy Intake and Brain Health in Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Dairy Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn if dairy food consumption may help brain health in&#xD;
      aging by protecting nerve cells from oxidative damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary dairy food intake measured using 7-day diet recording</measure>
    <time_frame>1 week, prior to MRS scan</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Aged Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Low dairy intake</arm_group_label>
    <description>1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Dairy Intake</arm_group_label>
    <description>1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recommended Dairy Intake</arm_group_label>
    <description>Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy elderly individuals with an age range of 60-85 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females between 60-85 years of age.&#xD;
&#xD;
          2. Good general health with no concomitant diseases, which would be expected to interfere&#xD;
             with the study&#xD;
&#xD;
          3. BMI range 20-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of any central neurological disease with the potential to impair&#xD;
             cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple&#xD;
             sclerosis, Alzheimer disease, Parkinson's disease) or prior major head trauma with&#xD;
             loss of consciousness&#xD;
&#xD;
          2. Presence of an active unstable and life-threatening systemic illness (e.g., cancer)&#xD;
&#xD;
          3. Presence of major psychiatric disorder within the past 3 years including depression,&#xD;
             anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse&#xD;
             (DSM-IV criteria; Geriatric Depression Score&gt;6)&#xD;
&#xD;
          4. Presence of diabetes mellitus (defined as a clinical diagnosis or use of an&#xD;
             anti-diabetic agent) and metabolic syndrome&#xD;
&#xD;
          5. Use of psychoactive and investigational medications&#xD;
&#xD;
          6. Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial&#xD;
             heart valves, metal fragments, foreign objects or claustrophobia. All subjects&#xD;
             subjects will receive a structural MRI as part of this study. Individuals with&#xD;
             evidence of infection, infarction, neoplasm or other lesions will be excluded.&#xD;
             Individuals found to have abnormalities in their structural MRI will be referred to&#xD;
             their primary physician for further evaluation and management.&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Special diet regimens such as lactose free or vegan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Young Choi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>March 19, 2017</last_update_submitted>
  <last_update_submitted_qc>March 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>In-Young Choi, Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glutathione</keyword>
  <keyword>Dairy consumption</keyword>
  <keyword>Brain</keyword>
  <keyword>Humans</keyword>
  <!-- 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/NCT02245035
org study id: 12884
nct id: NCT02245035
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to learn if dairy food consumption may help brain health in
      aging by protecting nerve cells from oxidative damage.
observational model: Case-Only
time perspective: Prospective
measure: Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)
time frame: Baseline
measure: Dietary dairy food intake measured using 7-day diet recording
time frame: 1 week, prior to MRS scan
arm group label: Low dairy intake
description: 1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall
arm group label: Moderate Dairy Intake
description: 1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall
arm group label: Recommended Dairy Intake
description: Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: In-Young Choi, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: In-Young Choi, Ph.D.
investigator title: Associate Professor