<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/NCT02986893</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 16-0288</org_study_id>
    <nct_id>NCT02986893</nct_id>
  </id_info>
  <brief_title>Pilot Diet Study for Multiple Sclerosis</brief_title>
  <official_title>Pilot Study of a Dietary Intervention for Multiple Sclerosis (MS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to establish the feasibility of dietary research in Multiple&#xD;
      Sclerosis (MS) patients as well as to provide preliminary data to support future clinical&#xD;
      trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in&#xD;
      MS patients. The dietary intervention was designed to include dietary components that have&#xD;
      been suggested to be of benefit in MS through basic science research and observational-type&#xD;
      studies in MS patients and to exclude those that have been suggested to be detrimental. It is&#xD;
      therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3&#xD;
      fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and&#xD;
      other fruits and vegetables, as well as whole grains, and excludes meat other than fish as&#xD;
      well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the&#xD;
      dietary intervention or to the non-intervention group. The non-intervention group will be&#xD;
      invited to attend regular meetings with a focus on wellness in MS however will not receive&#xD;
      specific dietary instructions. At the end of the study those who were not in the dietary&#xD;
      intervention group will have the opportunity to receive all of the materials used during the&#xD;
      study should they wish to begin the diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study of a carefully-designed dietary intervention that aims to help overcome&#xD;
      obstacles to diet research in MS as well as provide needed preliminary data for future&#xD;
      clinical trials. It incorporates elements with suggested benefits for MS including foods high&#xD;
      in polyunsaturated fatty acids, polyphenols, and antioxidants, and excludes those that are&#xD;
      potentially detrimental such as dairy and saturated fat from meat, refined sugars, and also&#xD;
      limits salt content.&#xD;
&#xD;
      The 15 participants randomized to the dietary intervention arm will undergo intensive&#xD;
      training with a nutritionist and the PI regarding the mechanics of the diet. Menu&#xD;
      suggestions, recipes, and grocery lists will be provided. This will be followed by regular&#xD;
      meetings and contact with all study participants by e-mail and phone to maximize dietary&#xD;
      adherence. The 15 subjects not in the dietary intervention group will have regular meetings&#xD;
      at the center with a focus on wellness in MS in general. Adherence to the diet will be&#xD;
      assessed through the use of multiple validated dietary questionnaires as well as through&#xD;
      biological specimen analysis. Feedback will be requested to provide valuable advice from&#xD;
      participants that can be applied to future clinical trials. Effects on general health and&#xD;
      wellness outcomes such as BMI, lipid profile, fasting glucose, hemoglobin a1c, blood&#xD;
      pressure, as well as effects on fatigue and cognition will be explored. Fecal specimens for&#xD;
      microbiota analysis and blood samples for immunological profiling will be collected and&#xD;
      stored for future analysis to help elucidate potential mechanisms for dietary effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food Frequency Questionnaire</measure>
    <time_frame>at 6 months</time_frame>
    <description>Adherence to the dietary intervention will be assessed through the food frequency questionnaire. This full-length (approximately 110 food item) questionnaire was designed to estimate usual and customary intake of a wide array of nutrients and food groups. Calculations are estimated via computerized software programs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carotenoids level</measure>
    <time_frame>at 6 months</time_frame>
    <description>Adherence to the dietary intervention assessed through the carotenoid biological marker.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled fatty acids level</measure>
    <time_frame>at 6 months</time_frame>
    <description>Adherence to the dietary intervention assessed through the pooled fatty acids biological marker.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary sodium level</measure>
    <time_frame>at 6 months</time_frame>
    <description>Adherence to the dietary intervention assessed through the urinary sodium biological marker.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Blood pressure</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Change in Blood pressure at 3 months and 6 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Change in body mass index at 3 months and 6 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change in lipid profile at 6 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting glucose level</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change in fasting glucose at 6 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin a1c level</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change in hemoglobin a1c at 6 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Impact Scale-29 at 3 months and 6 months as compared to baseline. The MSIS-29 is a new measure of the physical and psychological impact of MS from the patient's perspective. Each item is scored from 1 (not at all) to 5 (extremely), with total scale from 29 to 145.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Quality of Life-54 questionnaire at 3 months and 6 months as compared to baseline. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQOL-54. The MSQOL-54 items are transformed linearly to 0-100 scores and final scores are obtained by averaging items within the scales. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Minimum Assessment of Cognitive Function in MS (MACFIMS)</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change at 6 months from baseline. Total range of MACFIMS from 0 (severe impairment to 282 (severe impairment) which is composed of 7 neuropsychological tests: 1) Controlled Oral Word Association Test (COWAT) score 0 (nonverbal) to 22 (normal verbal fluency; 2) Judgment of Line Orientation (JLO) score 0 (no visuospatial skills) to 30 (normal visuospatial skills); 3) California Verbal Learning Test, 2nd ed (CLVT-II) score 0 (severe deficit) to 16 (normal recall); 4) Brief Visuospatial Memory Test-Revised (BVMT-R) score 0 (poor visuospatial memory) to 12 (normal visuospatial memory); 5) Paced Auditory Serial Addition Test (PASAT) score 0 (poor cognitive function) to 60 (normal cognitive function); 6) Delis-Kaplan Executive Function System (DKEFS) score 0 (poor cognitive function) to 32 (higher levels of creative and abstract thought ); and 7) Symbol Digit Modalities Test (SDMT) score 0 (neurological impairment) to 110 (no impairment ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological Fatigue Index-MS</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change in fatigue scale score (Neurological Fatigue Index-MS) at 6 months as compared to baseline. The Neurological Fatigue Index is a 9 item questionnaire with each item scored 1 (not appropriate) to 7 (agree). The score is calculated by the average response to the questions (adding up all the answers and dividing by 9). full range from 1 to 9 with higher value indicating more fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Dietary Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned to follow a specific dietary intervention for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-dietary Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will continue their usual diet and will be invited to attend monthly meetings at the MS Center for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Participants will be assigned to follow a specific diet for 6 months. This will involve meetings with the study nutritionist at least monthly as well as regular assessments related to adherence and effects.</description>
    <arm_group_label>Dietary Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-dietary Intervention Arm</intervention_name>
    <description>Participants will be requested to follow their usual diet and attend monthly meetings at the MS center to discuss various topics with a focus on wellness in MS for 6 months.</description>
    <arm_group_label>Non-dietary Intervention Arm</arm_group_label>
    <other_name>Monthly MS Center meeting attendance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65, inclusive&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Self-reported race of white or black&#xD;
&#xD;
          -  Diagnosis of CIS with MRI consistent with MS, RRMS, or PPMS by McDonald 2010 criteria&#xD;
             or SPMS by Lublin 2014 definition&#xD;
&#xD;
          -  If the subject is receiving treatment with disease-modifying therapy, must be on that&#xD;
             therapy for at least 3 months prior to randomization&#xD;
&#xD;
          -  Willing and able to be randomized to dietary intervention with commitment to&#xD;
             rigorously follow the dietary protocol and complete the necessary assessments over 6&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MS exacerbation within 60 days of protocol start&#xD;
&#xD;
          -  Intravenous corticosteroids within 60 days of protocol start&#xD;
&#xD;
          -  Patients with severe medical or psychiatric illness that would interfere with their&#xD;
             ability to comply with the protocol, or potentially cause the patient harm as&#xD;
             determined by the treating physician&#xD;
&#xD;
          -  Active smoking at the time of protocol start&#xD;
&#xD;
          -  Taking supplements other than approved doses of vitamin D within 1 month of study&#xD;
             start&#xD;
&#xD;
          -  Pregnancy or planning pregnancy during the study period, breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilana Katz Sand, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 2, 2018</last_update_submitted>
  <last_update_submitted_qc>October 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Diet</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT02986893
org study id: GCO 16-0288
nct id: NCT02986893
lead sponsor: 
has dmc: No
The goal of this project is to establish the feasibility of dietary research in Multiple
      Sclerosis (MS) patients as well as to provide preliminary data to support future clinical
      trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in
      MS patients. The dietary intervention was designed to include dietary components that have
      been suggested to be of benefit in MS through basic science research and observational-type
      studies in MS patients and to exclude those that have been suggested to be detrimental. It is
      therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3
      fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and
      other fruits and vegetables, as well as whole grains, and excludes meat other than fish as
      well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the
      dietary intervention or to the non-intervention group. The non-intervention group will be
      invited to attend regular meetings with a focus on wellness in MS however will not receive
      specific dietary instructions. At the end of the study those who were not in the dietary
      intervention group will have the opportunity to receive all of the materials used during the
      study should they wish to begin the diet.
This is a pilot study of a carefully-designed dietary intervention that aims to help overcome
      obstacles to diet research in MS as well as provide needed preliminary data for future
      clinical trials. It incorporates elements with suggested benefits for MS including foods high
      in polyunsaturated fatty acids, polyphenols, and antioxidants, and excludes those that are
      potentially detrimental such as dairy and saturated fat from meat, refined sugars, and also
      limits salt content.

      The 15 participants randomized to the dietary intervention arm will undergo intensive
      training with a nutritionist and the PI regarding the mechanics of the diet. Menu
      suggestions, recipes, and grocery lists will be provided. This will be followed by regular
      meetings and contact with all study participants by e-mail and phone to maximize dietary
      adherence. The 15 subjects not in the dietary intervention group will have regular meetings
      at the center with a focus on wellness in MS in general. Adherence to the diet will be
      assessed through the use of multiple validated dietary questionnaires as well as through
      biological specimen analysis. Feedback will be requested to provide valuable advice from
      participants that can be applied to future clinical trials. Effects on general health and
      wellness outcomes such as BMI, lipid profile, fasting glucose, hemoglobin a1c, blood
      pressure, as well as effects on fatigue and cognition will be explored. Fecal specimens for
      microbiota analysis and blood samples for immunological profiling will be collected and
      stored for future analysis to help elucidate potential mechanisms for dietary effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Food Frequency Questionnaire
time frame: at 6 months
description: Adherence to the dietary intervention will be assessed through the food frequency questionnaire. This full-length (approximately 110 food item) questionnaire was designed to estimate usual and customary intake of a wide array of nutrients and food groups. Calculations are estimated via computerized software programs.
measure: Carotenoids level
time frame: at 6 months
description: Adherence to the dietary intervention assessed through the carotenoid biological marker.
measure: Pooled fatty acids level
time frame: at 6 months
description: Adherence to the dietary intervention assessed through the pooled fatty acids biological marker.
measure: Urinary sodium level
time frame: at 6 months
description: Adherence to the dietary intervention assessed through the urinary sodium biological marker.
measure: Change in Blood pressure
time frame: Baseline, 3 months, 6 months
description: Change in Blood pressure at 3 months and 6 months as compared to baseline
measure: Change in body mass index
time frame: Baseline, 3 months, 6 months
description: Change in body mass index at 3 months and 6 months as compared to baseline
measure: Change in lipid profile
time frame: Baseline, 6 months
description: Change in lipid profile at 6 months as compared to baseline
measure: Change in fasting glucose level
time frame: Baseline, 6 months
description: Change in fasting glucose at 6 months as compared to baseline
measure: Change in hemoglobin a1c level
time frame: Baseline, 6 months
description: Change in hemoglobin a1c at 6 months as compared to baseline
measure: Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)
time frame: Baseline, 3 months, 6 months
description: Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Impact Scale-29 at 3 months and 6 months as compared to baseline. The MSIS-29 is a new measure of the physical and psychological impact of MS from the patient's perspective. Each item is scored from 1 (not at all) to 5 (extremely), with total scale from 29 to 145.
measure: Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)
time frame: Baseline, 3 months, 6 months
description: Change in quality of life questionnaire scores as assessed by the Multiple Sclerosis Quality of Life-54 questionnaire at 3 months and 6 months as compared to baseline. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQOL-54. The MSQOL-54 items are transformed linearly to 0-100 scores and final scores are obtained by averaging items within the scales. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
measure: Change in the Minimum Assessment of Cognitive Function in MS (MACFIMS)
time frame: Baseline, 6 months
description: Change at 6 months from baseline. Total range of MACFIMS from 0 (severe impairment to 282 (severe impairment) which is composed of 7 neuropsychological tests: 1) Controlled Oral Word Association Test (COWAT) score 0 (nonverbal) to 22 (normal verbal fluency; 2) Judgment of Line Orientation (JLO) score 0 (no visuospatial skills) to 30 (normal visuospatial skills); 3) California Verbal Learning Test, 2nd ed (CLVT-II) score 0 (severe deficit) to 16 (normal recall); 4) Brief Visuospatial Memory Test-Revised (BVMT-R) score 0 (poor visuospatial memory) to 12 (normal visuospatial memory); 5) Paced Auditory Serial Addition Test (PASAT) score 0 (poor cognitive function) to 60 (normal cognitive function); 6) Delis-Kaplan Executive Function System (DKEFS) score 0 (poor cognitive function) to 32 (higher levels of creative and abstract thought ); and 7) Symbol Digit Modalities Test (SDMT) score 0 (neurological impairment) to 110 (no impairment ).
measure: Neurological Fatigue Index-MS
time frame: Baseline, 6 months
description: Change in fatigue scale score (Neurological Fatigue Index-MS) at 6 months as compared to baseline. The Neurological Fatigue Index is a 9 item questionnaire with each item scored 1 (not appropriate) to 7 (agree). The score is calculated by the average response to the questions (adding up all the answers and dividing by 9). full range from 1 to 9 with higher value indicating more fatigue.
arm group label: Dietary Intervention Arm
arm group type: Experimental
description: Participants will be assigned to follow a specific dietary intervention for 6 months
arm group label: Non-dietary Intervention Arm
arm group type: Experimental
description: Participants will continue their usual diet and will be invited to attend monthly meetings at the MS Center for 6 months
intervention type: Behavioral
intervention name: Dietary Intervention
description: Participants will be assigned to follow a specific diet for 6 months. This will involve meetings with the study nutritionist at least monthly as well as regular assessments related to adherence and effects.
arm group label: Dietary Intervention Arm
intervention type: Behavioral
intervention name: Non-dietary Intervention Arm
description: Participants will be requested to follow their usual diet and attend monthly meetings at the MS center to discuss various topics with a focus on wellness in MS for 6 months.
arm group label: Non-dietary Intervention Arm
other name: Monthly MS Center meeting attendance
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ilana Katz Sand, MD
role: Principal Investigator
affiliation: Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No