xml: <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/NCT06039007</url>
    </required_header>
    <id_info>
      <org_study_id>FAST-MS</org_study_id>
      <nct_id>NCT06039007</nct_id>
    </id_info>
    <brief_title>A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis</brief_title>
    <acronym>FAST-MS</acronym>
    <official_title>A run-in Study on the Safety and Tolerability of a Fasting Mimicking Diet in Relapsing Remitting Multiple Sclerosis (FAST-MS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ospedale Policlinico San Martino</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ospedale Policlinico San Martino</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>
        This study is an open-label, single-arm, run-in study in patients with RRMS treated with&#xD;
        first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl&#xD;
        fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet&#xD;
        (FMD) over 6 months. All eligible patients will receive 3 cycles of the FMD once every 60&#xD;
        days in addition to their standard therapy with first line therapies. The diet provides&#xD;
        1100kcal on day 1 and 800 kcal on days 2-7. The diet consists of ingredients which are&#xD;
        Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of the present study is to evaluate the safety and tolerability of 3&#xD;
        cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS&#xD;
        treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and&#xD;
        dimethyl fumarate). The primary endpoint is the number of serious and/or severe adverse&#xD;
        events after the FMD start. A nutritionist will follow the patients for all the 6 months&#xD;
        period, with the aim to monitor the FMD effects and to check for any possible problems. The&#xD;
        nutritionist will call the patient on day 1 of every FMD cycle to answer any questions and&#xD;
        check on the response, and on day 5 of the FMD to check on side effects and adherence.&#xD;
  &#xD;
        At scheduled visits, vital signs and adverse events will be recorded from every patient.&#xD;
  &#xD;
        Blood samples will be collected at baseline and just before at day 7 before returning to the&#xD;
        normal diet on cycle 1 and 1 week after the first, the second and third FMD cycles. Should&#xD;
        the patient display abnormal counts, the CBC will be repeated one week later. Additional FMD&#xD;
        cycles will not be allowed in patients who do not return to normal levels of White Blood&#xD;
        Cells (WBC) and Red Blood Cells (RBC).&#xD;
  &#xD;
        At scheduled visits, vital signs and adverse events will be recorded from every patient.&#xD;
  &#xD;
        FMD will be administered at month 0, month 2 and month 4 (3 cycles). MRI will be done at&#xD;
        baseline and at month 6. At baseline and at month 6 patients will be evaluated with the EDSS&#xD;
        and MSFC Functional composite scale. At the same time points, patients will be examined for&#xD;
        the presence of cognitive disturbances by the Brief International Cognitive Assessment in&#xD;
        Multiple Sclerosis (BICAMS) battery , of anxiety and depressive symptoms by the Hospital&#xD;
        Anxiety and Depression Scale (HADS) , of fatigue by the Modified Fatigue Impact Scale (MFIS)&#xD;
        , while quality of life will be monitored using the Short Form 36 Health Survey (SF-36) . A&#xD;
        nutritional assessment will be carried out at enrollment and before every FMD cycle: patients&#xD;
        will be examined evaluating the height and weight, with determination of the BMI; the bodily&#xD;
        composition will be measured with a dynamometer and by BIA.&#xD;
  &#xD;
        Adverse events (AEs) will be monitored for each patient up to the study termination; in case&#xD;
        of ongoing AEs at study end, patients will be followed for 30 additional days.&#xD;
  &#xD;
        During the whole duration of the study, patients will be instructed to perform standardized&#xD;
        physical exercises, in order to avoid fasting induced sarcopenia. Briefly, before each FMD&#xD;
        cycle, patients will be recommended to exercise 30 minutes daily according to a dedicated&#xD;
        training program to improve their muscle anabolism in the interval between the three FMD&#xD;
        cycles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">December 16, 2019</start_date>
    <completion_date type="Anticipated">September 4, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and tolerability of 7-day FMD</measure>
      <time_frame>6 months</time_frame>
      <description>Safety of 7-day FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status.&#xD;
  To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing &gt; grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle &lt;5° assessed with bio-impedance measurements. for Adverse Events (CTCAE)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients able to achieve the designated diet regimen</measure>
      <time_frame>6 months</time_frame>
      <description>Feasibility of FMD in terms of percentage of patients able to complete the diet regimen To evaluate the feasibility of the FMD in MCI and AD patients as assessed by the percentage of patients (%) able to achieve the designated diet regimen.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the Expanded Disability Status Scale (EDSS)</measure>
      <time_frame>6 months</time_frame>
      <description>Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Body Mass Index (BMI)</measure>
      <time_frame>6 months</time_frame>
      <description>kg/m2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the serum light chain neurofilaments concentration</measure>
      <time_frame>6 months</time_frame>
      <description>ng/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>White Blood Cells</measure>
      <time_frame>6 months</time_frame>
      <description>mil/mm3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of the FMD in terms of nutritional state</measure>
      <time_frame>6 months</time_frame>
      <description>Efficacy of the FMD in terms of nutritional state will be assessed with phase angle with bioimpedance (°)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>7-DAY FMD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The 7-DAY FMD by L-Nutra is a low-calorie and low-protein diet that provides all the necessary micronutrients to prevent malnutrition. This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. The diet consists of ingredients that are Generally Regarded As Safe (GRAS), selected for their fasting mimicking properties. Patients will take the 7-DAY FMD once every 60 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>7-day Fasting-Mimicking Diet (7-DAY FMD)</intervention_name>
      <description>This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day.</description>
      <arm_group_label>7-DAY FMD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of RRMS (Thompson et al. 2018);&#xD;
  &#xD;
            -  Disease duration 6 months to 10 years (included);&#xD;
  &#xD;
            -  EDSS 0 to 4, 5;&#xD;
  &#xD;
            -  Treatment with first line therapies (interferon-beta, glatiramer acetate,&#xD;
               teriflunomide and dimethyl fumarate).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt; 6 months since treatment start with first line therapies (interferon-beta,&#xD;
               glatiramer acetate, teriflunomide and dimethyl fumarate);&#xD;
  &#xD;
            -  Relapse &lt; 60 days;&#xD;
  &#xD;
            -  Any active or chronic infection;&#xD;
  &#xD;
            -  Previous history of a malignancy other than basal cell carcinoma of the skin or&#xD;
               carcinoma in situ that has been in remission for more than one year;&#xD;
  &#xD;
            -  Severely limited life expectancy by another co-morbid illness;&#xD;
  &#xD;
            -  Nutritional risk screening (NRS 2002) &gt; or = 3;&#xD;
  &#xD;
            -  BMI &lt;= 18.5 kg/m2;&#xD;
  &#xD;
            -  Bio-impedance phase angle &lt;5.0°;&#xD;
  &#xD;
            -  History of previous diagnosis of myelodysplasia or previous hematologic disease or&#xD;
               current clinically relevant abnormalities of white blood cell counts;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ospedale San Martino</name>
        <address>
          <city>Genova</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>fasting mimicking diet</keyword>
    <keyword>multiple sclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039007
  org study id: FAST-MS
  nct id: NCT06039007
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is an open-label, single-arm, run-in study in patients with RRMS treated with
        first line therapies (interferon-beta, glatiramer acetate, teriflunomide and dimethyl
        fumarate), assessing the feasibility and tolerability of 3 cycles of Fasting-Mimicking Diet
        (FMD) over 6 months. All eligible patients will receive 3 cycles of the FMD once every 60
        days in addition to their standard therapy with first line therapies. The diet provides
        1100kcal on day 1 and 800 kcal on days 2-7. The diet consists of ingredients which are
        Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.
  The primary objective of the present study is to evaluate the safety and tolerability of 3
        cycles of a 7 days FMD as a potential support to the management of patients affected by RRMS
        treated with first line therapies (interferon-beta, glatiramer acetate, teriflunomide and
        dimethyl fumarate). The primary endpoint is the number of serious and/or severe adverse
        events after the FMD start. A nutritionist will follow the patients for all the 6 months
        period, with the aim to monitor the FMD effects and to check for any possible problems. The
        nutritionist will call the patient on day 1 of every FMD cycle to answer any questions and
        check on the response, and on day 5 of the FMD to check on side effects and adherence.
  
        At scheduled visits, vital signs and adverse events will be recorded from every patient.
  
        Blood samples will be collected at baseline and just before at day 7 before returning to the
        normal diet on cycle 1 and 1 week after the first, the second and third FMD cycles. Should
        the patient display abnormal counts, the CBC will be repeated one week later. Additional FMD
        cycles will not be allowed in patients who do not return to normal levels of White Blood
        Cells (WBC) and Red Blood Cells (RBC).
  
        At scheduled visits, vital signs and adverse events will be recorded from every patient.
  
        FMD will be administered at month 0, month 2 and month 4 (3 cycles). MRI will be done at
        baseline and at month 6. At baseline and at month 6 patients will be evaluated with the EDSS
        and MSFC Functional composite scale. At the same time points, patients will be examined for
        the presence of cognitive disturbances by the Brief International Cognitive Assessment in
        Multiple Sclerosis (BICAMS) battery , of anxiety and depressive symptoms by the Hospital
        Anxiety and Depression Scale (HADS) , of fatigue by the Modified Fatigue Impact Scale (MFIS)
        , while quality of life will be monitored using the Short Form 36 Health Survey (SF-36) . A
        nutritional assessment will be carried out at enrollment and before every FMD cycle: patients
        will be examined evaluating the height and weight, with determination of the BMI; the bodily
        composition will be measured with a dynamometer and by BIA.
  
        Adverse events (AEs) will be monitored for each patient up to the study termination; in case
        of ongoing AEs at study end, patients will be followed for 30 additional days.
  
        During the whole duration of the study, patients will be instructed to perform standardized
        physical exercises, in order to avoid fasting induced sarcopenia. Briefly, before each FMD
        cycle, patients will be recommended to exercise 30 minutes daily according to a dedicated
        training program to improve their muscle anabolism in the interval between the three FMD
        cycles.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety and tolerability of 7-day FMD
  time frame: 6 months
  description: Safety of 7-day FMD in terms of percentage of patients experiencing adverse events and/or worsening of nutritional status.
  To obtain clinical data on safety of the FMD in MCI or AD patients as assessed by percentage of patients (%) experiencing > grade 3 adverse events and/or a significant decrease in their lean body mass (kg) and/or with a reduction of phase angle <5° assessed with bio-impedance measurements. for Adverse Events (CTCAE)
  measure: Percentage of patients able to achieve the designated diet regimen
  time frame: 6 months
  description: Feasibility of FMD in terms of percentage of patients able to complete the diet regimen To evaluate the feasibility of the FMD in MCI and AD patients as assessed by the percentage of patients (%) able to achieve the designated diet regimen.
  measure: Changes in the Expanded Disability Status Scale (EDSS)
  time frame: 6 months
  description: Score
  measure: Changes in Body Mass Index (BMI)
  time frame: 6 months
  description: kg/m2
  measure: Changes in the serum light chain neurofilaments concentration
  time frame: 6 months
  description: ng/ml
  measure: White Blood Cells
  time frame: 6 months
  description: mil/mm3
  measure: Efficacy of the FMD in terms of nutritional state
  time frame: 6 months
  description: Efficacy of the FMD in terms of nutritional state will be assessed with phase angle with bioimpedance (°)
  arm group label: 7-DAY FMD
  arm group type: Experimental
  description: The 7-DAY FMD by L-Nutra is a low-calorie and low-protein diet that provides all the necessary micronutrients to prevent malnutrition. This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day. The diet consists of ingredients that are Generally Regarded As Safe (GRAS), selected for their fasting mimicking properties. Patients will take the 7-DAY FMD once every 60 days.
  intervention type: Dietary Supplement
  intervention name: 7-day Fasting-Mimicking Diet (7-DAY FMD)
  description: This medically-designed dietary kit supplies food for 7 days, with Day 1 providing 1100 kcal, while days 2 to 5 provide 800 kcal per day.
  arm group label: 7-DAY FMD
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Multiple Sclerosis, Relapsing-Remitting
  mesh term: Sclerosis