<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/NCT04490252</url>
  </required_header>
  <id_info>
    <org_study_id>FMD1</org_study_id>
    <nct_id>NCT04490252</nct_id>
  </id_info>
  <brief_title>Effects of Fasting Mimetic Diet on Nephropatic Patients</brief_title>
  <official_title>Effects of Fasting Mimetic Diet on Nephropatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the&#xD;
      trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD),&#xD;
      through the stimulation of kidney stem cells and improving cardiovascular and metabolic&#xD;
      status.&#xD;
&#xD;
      From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary&#xD;
      glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are:&#xD;
      age &lt;18 y.o., age&gt; 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious&#xD;
      diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of&#xD;
      stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed&#xD;
      consent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Creatinine (mg/dl)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood urea (mg/dl)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive C-protein (mg/L)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood glucose (mg/dl)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPTH (ng/ml)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total protein (g/L)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood insulin (mcUI/ml)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood uric acid (mg/dl)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow-mediated dilation (%)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intima-media thickness (mm)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal resistive index (dimensionless)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epicardial Adipose Tissue (cm)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck depression inventory II (BDI-II) (0 to 63 points)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI (kg/m^2)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <arm_group>
    <arm_group_label>Free diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Free diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasting mimetic diet for 5 days, next cycle after 25 days of free diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fasting mimetic diet</intervention_name>
    <description>Fasting mimetic diet for 5 days, another cycle after 25 days</description>
    <arm_group_label>FMD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of primary glomerulonephritis&#xD;
&#xD;
          -  eGFR between 60 ml/min and 30 ml/min&#xD;
&#xD;
          -  age between 18-65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary GMN&#xD;
&#xD;
          -  severe heart failure (NYHA IV)&#xD;
&#xD;
          -  ongoing infectious diseases&#xD;
&#xD;
          -  ongoing neoplasia,&#xD;
&#xD;
          -  hepatic diseases&#xD;
&#xD;
          -  COPD,&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  history of stroke&#xD;
&#xD;
          -  history of acute coronary disease less than 3 months&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  refuse informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Lai, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rome &quot;Sapienza&quot;- Department of Translational and Precision Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital &quot;Umberto I&quot;, University of Rome &quot;Sapienza&quot;</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Silvia Lai</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Fasting mimetic diet</keyword>
  <keyword>Kidney stem cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT04490252
org study id: FMD1
nct id: NCT04490252
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the
      trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD),
      through the stimulation of kidney stem cells and improving cardiovascular and metabolic
      status.

      From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary
      glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are:
      age <18 y.o., age> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious
      diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of
      stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed
      consent.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
time frame: Baseline to 6 months
measure: Creatinine (mg/dl)
time frame: Baseline to 6 months
measure: Blood urea (mg/dl)
time frame: Baseline to 6 months
measure: Reactive C-protein (mg/L)
time frame: Baseline to 6 months
measure: Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)
time frame: Baseline to 6 months
measure: blood glucose (mg/dl)
time frame: Baseline to 6 months
measure: iPTH (ng/ml)
time frame: Baseline to 6 months
measure: Total protein (g/L)
time frame: Baseline to 6 months
measure: Blood insulin (mcUI/ml)
time frame: Baseline to 6 months
measure: Blood uric acid (mg/dl)
time frame: Baseline to 6 months
measure: Flow-mediated dilation (%)
time frame: Baseline to 6 months
measure: Intima-media thickness (mm)
time frame: Baseline to 6 months
measure: eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)
time frame: Baseline to 6 months
measure: Renal resistive index (dimensionless)
time frame: Baseline to 6 months
measure: Epicardial Adipose Tissue (cm)
time frame: Baseline to 6 months
measure: Beck depression inventory II (BDI-II) (0 to 63 points)
time frame: Baseline to 6 months
measure: BMI (kg/m^2)
time frame: Baseline to 6 months
arm group label: Free diet
arm group type: No Intervention
description: Free diet
arm group label: FMD
arm group type: Experimental
description: Fasting mimetic diet for 5 days, next cycle after 25 days of free diet
intervention type: Dietary Supplement
intervention name: Fasting mimetic diet
description: Fasting mimetic diet for 5 days, another cycle after 25 days
arm group label: FMD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Silvia Lai, Prof.
role: Principal Investigator
affiliation: University of Rome "Sapienza"- Department of Translational and Precision Medicine
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Silvia Lai
investigator title: Professor
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
sharing ipd: No