<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/NCT03240406</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6613</org_study_id>
    <secondary_id>R01AG055527</secondary_id>
    <nct_id>NCT03240406</nct_id>
  </id_info>
  <brief_title>Multicultural Healthy Diet to Reduce Cognitive Decline</brief_title>
  <acronym>MHD</acronym>
  <official_title>Multicultural Healthy Diet to Reduce Cognitive Decline &amp; Alzheimer's Disease Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a pilot randomized controlled clinical trial is designed to investigate whether the&#xD;
      Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural&#xD;
      population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in&#xD;
      Bronx, New York compared to a usual diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Multicultural Healthy Diet (MHD) is a pilot randomized controlled clinical trial designed&#xD;
      to test the effects of an 18 month intervention on cognitive function among 290 middle-aged&#xD;
      individuals (40-65 yr). MHD is an anti-inflammatory diet tailored to a multicultural&#xD;
      population. The emphasis of the intervention is on plant-based foods and limited animal and&#xD;
      high saturated fat foods with focus on anti-inflammatory foods/food components specific to&#xD;
      the cultural context of the participants. The trial will employ a parallel group design&#xD;
      comparing the effects of the dietary intervention (MHD) on cognitive status to those of the&#xD;
      control diet or usual diet plus modules on self-care matters such as dealing with aches and&#xD;
      pains of aging, obtaining a health care proxy ,etc. To show that MHD can be adapted to this&#xD;
      population serum biomarkers indicative of the MHD diet pattern such as fatty acid profile as&#xD;
      well as other key nutrition biomarkers will be evaluated. Other aims include testing whether&#xD;
      the MHD intervention can benefit cognitive function using real-time ambulatory assessments.&#xD;
      The investigators will also assess plasma markers of oxidative stress and inflammation.&#xD;
      Components of the MHD diet that are associated with stable or improved measures of cognition&#xD;
      will also be evaluated. The clinical site for the proposed study is at the Albert Einstein&#xD;
      College of Medicine; the ambulatory cognitive assessment reading center is at Pennsylvania&#xD;
      State University, State College; the statistical core is at the Kaiser Permanente Washington&#xD;
      Health Research Institute and the laboratory for biospecimen analysis is at the University of&#xD;
      Minnesota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">July 3, 2023</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>
    <intervention_model_description>This is a pilot randomized clinical trial to the effects of an anti-inflammatory diet on cognition in a middle-aged cohort. The comparison arm will receive information on self-care matters such as aches and pains of aging.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The research clinician who assesses cognitive status needs to be blinded to assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in composite cognition score</measure>
    <time_frame>9 months post baseline</time_frame>
    <description>9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing visuospatial working memory, processing speed and short-term associative memory binding. Composite score is based on the average of z-scores of the individual test scores.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">290</enrollment>
  <condition>Diet Modification</condition>
  <condition>Cognitive Decline</condition>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Anti-inflammatory dietary intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Diet plus Self-Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>18 month intervention of usual diet plus self-care modules</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multicultural Healthy Diet</intervention_name>
    <description>An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential</description>
    <arm_group_label>Anti-inflammatory dietary intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Diet plus Self-Care</intervention_name>
    <description>Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.</description>
    <arm_group_label>Usual Diet plus Self-Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  living, working, attending school or visiting Co-op City, Bronx (e.g. for shopping,&#xD;
             doctors' visits, etc.) or communities neighboring Co-op City and between 40-65 yr of&#xD;
             age&#xD;
&#xD;
          -  willingness to accept assignment to intervention or comparison diet group&#xD;
&#xD;
          -  willingness to participate in a study where weight loss is not a primary goal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitively impaired&#xD;
&#xD;
          -  history of traumatic brain injury&#xD;
&#xD;
          -  psychiatric illness&#xD;
&#xD;
          -  history of diabetes and experiencing hypoglycemia&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  uncontrolled hypertension as defined as blood pressure &gt; 140/90 mm Hg&#xD;
&#xD;
          -  history of cardiovascular disease that affects physical functioning&#xD;
&#xD;
          -  severe chronic illness&#xD;
&#xD;
          -  low literacy&#xD;
&#xD;
          -  history of alcohol or drug dependence&#xD;
&#xD;
          -  hematologic disease or malignancy not in remission for more than 5 years&#xD;
&#xD;
          -  visual, auditory, or motor impairment that precludes cognitive testing.&#xD;
&#xD;
          -  chronic kidney disease on dialysis or special diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasmin Mossavar-Rahmani, Ph.D, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mossavar-Rahmani Y, Shaw PA, Hakun JG, Katz MJ, Wylie-Rosett J, Sliwinski MJ. Multicultural Healthy Diet to Reduce Cognitive Decline &amp; Alzheimer's Disease Risk: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2023 Jan;124:107006. doi: 10.1016/j.cct.2022.107006. Epub 2022 Nov 14.</citation>
    <PMID>36396064</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
    <investigator_full_name>Yasmin Mossavar-Rahmani</investigator_full_name>
    <investigator_title>Professor of Epidemiology &amp; Population Health</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Reasonable time after completion of data analysis and key manuscripts</ipd_time_frame>
    <ipd_access_criteria>Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines.</ipd_access_criteria>
  </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/NCT03240406
org study id: 2016-6613
secondary id: R01AG055527
nct id: NCT03240406
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a pilot randomized controlled clinical trial is designed to investigate whether the
      Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural
      population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in
      Bronx, New York compared to a usual diet.
The Multicultural Healthy Diet (MHD) is a pilot randomized controlled clinical trial designed
      to test the effects of an 18 month intervention on cognitive function among 290 middle-aged
      individuals (40-65 yr). MHD is an anti-inflammatory diet tailored to a multicultural
      population. The emphasis of the intervention is on plant-based foods and limited animal and
      high saturated fat foods with focus on anti-inflammatory foods/food components specific to
      the cultural context of the participants. The trial will employ a parallel group design
      comparing the effects of the dietary intervention (MHD) on cognitive status to those of the
      control diet or usual diet plus modules on self-care matters such as dealing with aches and
      pains of aging, obtaining a health care proxy ,etc. To show that MHD can be adapted to this
      population serum biomarkers indicative of the MHD diet pattern such as fatty acid profile as
      well as other key nutrition biomarkers will be evaluated. Other aims include testing whether
      the MHD intervention can benefit cognitive function using real-time ambulatory assessments.
      The investigators will also assess plasma markers of oxidative stress and inflammation.
      Components of the MHD diet that are associated with stable or improved measures of cognition
      will also be evaluated. The clinical site for the proposed study is at the Albert Einstein
      College of Medicine; the ambulatory cognitive assessment reading center is at Pennsylvania
      State University, State College; the statistical core is at the Kaiser Permanente Washington
      Health Research Institute and the laboratory for biospecimen analysis is at the University of
      Minnesota.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a pilot randomized clinical trial to the effects of an anti-inflammatory diet on cognition in a middle-aged cohort. The comparison arm will receive information on self-care matters such as aches and pains of aging.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The research clinician who assesses cognitive status needs to be blinded to assignment.
measure: Change in composite cognition score
time frame: 9 months post baseline
description: 9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing visuospatial working memory, processing speed and short-term associative memory binding. Composite score is based on the average of z-scores of the individual test scores.
arm group label: Anti-inflammatory dietary intervention
arm group type: Active Comparator
description: 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
arm group label: Usual Diet plus Self-Care
arm group type: Placebo Comparator
description: 18 month intervention of usual diet plus self-care modules
intervention type: Other
intervention name: Multicultural Healthy Diet
description: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential
arm group label: Anti-inflammatory dietary intervention
intervention type: Other
intervention name: Usual Diet plus Self-Care
description: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
arm group label: Usual Diet plus Self-Care
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yasmin Mossavar-Rahmani, Ph.D, RD
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
facility: 
country: United States
citation: Mossavar-Rahmani Y, Shaw PA, Hakun JG, Katz MJ, Wylie-Rosett J, Sliwinski MJ. Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2023 Jan;124:107006. doi: 10.1016/j.cct.2022.107006. Epub 2022 Nov 14.
PMID: 36396064
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein College of Medicine
investigator full name: Yasmin Mossavar-Rahmani
investigator title: Professor of Epidemiology & Population Health
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines
ipd info type: Study Protocol
ipd time frame: Reasonable time after completion of data analysis and key manuscripts
ipd access criteria: Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines.