<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/NCT04507516</url>
  </required_header>
  <id_info>
    <org_study_id>TNHF2018-1</org_study_id>
    <nct_id>NCT04507516</nct_id>
  </id_info>
  <brief_title>Fasting for Brain and Heart Health (FBHH)</brief_title>
  <acronym>FBHH</acronym>
  <official_title>A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TrueNorth Health Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TrueNorth Health Foundation</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 pilot study is designed to investigate the effect of water-only fasting and refeeding on&#xD;
      the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ischemic stroke is a leading cause of death and a major public health burden. Data suggests&#xD;
      that insulin resistance is a potential risk factor for cardiovascular disease, including&#xD;
      ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as&#xD;
      well as these disease risks. Nonetheless, current intervention strategies have done little to&#xD;
      reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically&#xD;
      supervised water-only fasting, might be an effective strategy to both reduce insulin&#xD;
      resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.&#xD;
&#xD;
      This pilot study is designed to investigate the effect of water-only fasting and refeeding on&#xD;
      the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.&#xD;
      Additionally, the study will assess if markers of cardiovascular health and inflammation&#xD;
      change before and after water-only fasting. Water-only fasting participants will be recruited&#xD;
      from patients who voluntarily elect to water-only fast for 10 or more consecutive days.&#xD;
      Clinical variables and blood will be collected at baseline, every 7th day during fasting and&#xD;
      refeeding, and the final day of fasting and refeeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2019</start_date>
  <completion_date type="Actual">February 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in insulin resistance from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid profile from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>Weight measured on a digital scale and reported in kilograms (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>SBP and DBP measured using digital blood pressure device and reported in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in abdominal circumference from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in high sensitivity C-reactive protein (hsCRP) from baseline</measure>
    <time_frame>Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast</time_frame>
    <description>hsCRP assessed using serum and reported in mg/L</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Water-only Fasting Cohort</arm_group_label>
    <description>Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water-only Fasting</intervention_name>
    <description>Water-only fasting for at least 10 days followed by 5 days of refeed.</description>
    <arm_group_label>Water-only Fasting Cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, sera&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Overweight and obese, non-diabetic participants recruited from voluntary patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any gender&#xD;
&#xD;
          -  40-70 years old&#xD;
&#xD;
          -  Fasting plasma glucose &lt;12 6mg/dL and/or hemoglobin A1c &lt;7%&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;25 kg/m2&#xD;
&#xD;
          -  Elect and qualify for a water-only fast of at least 10 consecutive days&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Active inflammatory disorder including classic autoimmune connective tissue (Lupus,&#xD;
             Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative&#xD;
             colitis, Crohn's)&#xD;
&#xD;
          -  Stroke or heart attack within the last 90 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Toshia R Myers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TrueNorth Health Center</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04507516
org study id: TNHF2018-1
nct id: NCT04507516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is designed to investigate the effect of water-only fasting and refeeding on
      the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
Ischemic stroke is a leading cause of death and a major public health burden. Data suggests
      that insulin resistance is a potential risk factor for cardiovascular disease, including
      ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as
      well as these disease risks. Nonetheless, current intervention strategies have done little to
      reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically
      supervised water-only fasting, might be an effective strategy to both reduce insulin
      resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.

      This pilot study is designed to investigate the effect of water-only fasting and refeeding on
      the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
      Additionally, the study will assess if markers of cardiovascular health and inflammation
      change before and after water-only fasting. Water-only fasting participants will be recruited
      from patients who voluntarily elect to water-only fast for 10 or more consecutive days.
      Clinical variables and blood will be collected at baseline, every 7th day during fasting and
      refeeding, and the final day of fasting and refeeding.
observational model: Cohort
time perspective: Prospective
measure: Changes in insulin resistance from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5]
measure: Changes in lipid profile from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL
measure: Changes in weight from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: Weight measured on a digital scale and reported in kilograms (kg)
measure: Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: SBP and DBP measured using digital blood pressure device and reported in mmHg
measure: Changes in abdominal circumference from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm)
measure: Changes in high sensitivity C-reactive protein (hsCRP) from baseline
time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
description: hsCRP assessed using serum and reported in mg/L
arm group label: Water-only Fasting Cohort
description: Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
intervention type: Other
intervention name: Water-only Fasting
description: Water-only fasting for at least 10 days followed by 5 days of refeed.
arm group label: Water-only Fasting Cohort
plasma, sera
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
last name: Toshia R Myers, PhD
role: Principal Investigator
affiliation: Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: Undecided