<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/NCT03754920</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiUTCMjialijun</org_study_id>
    <nct_id>NCT03754920</nct_id>
  </id_info>
  <brief_title>Prolonged Fasting With Meditation and Mild Physical Exercise</brief_title>
  <official_title>The Physical and Mental Effects of Prolonged Fasting With Meditation and Mild Physical Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</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>
      To determine the feasibility, safety and efficacy of fasting, participants are recruited in a&#xD;
      5-days fasting ( without any food, except unlimited mineral water),and do some fitness&#xD;
      regimen (such as meditation and mild physical exercise ) during fasting.The samples will be&#xD;
      collected from participates and subjected to comprehensive analysis ,including routine&#xD;
      medical examination in blood, metabonomics and proteomics anlysis in serum and urine samples,&#xD;
      gut microbiome analysis in stood samples, and so on.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Recruiting: 45 healthy people will be included in the clinical trial according to the&#xD;
           Inclusion criteria and exclusion criteria.&#xD;
&#xD;
        2. Fasting : Participants fast for five days, without any food, except unlimited mineral&#xD;
           water. Participants will do some fitness regimen (such as meditation and mild physical&#xD;
           exercise ) during fasting.&#xD;
&#xD;
        3. Re-feeding: Gradually distribute participants with rice flour, porridge and juice in the&#xD;
           next 3 days.&#xD;
&#xD;
        4. Follow-up :The health checklist is similar with that during fasting on the first month.&#xD;
&#xD;
        5. Data processing, statistics and analysis. Diet monitoring: The intake of glucose&#xD;
           decreases, while the burning of fat increases, which can down-regulate glucose level in&#xD;
           blood, up-regulate ketone level in urine. Thus, the fasting situation of participants&#xD;
           can be monitored by the variation of blood glucose and urine ketone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 9, 2018</start_date>
  <completion_date type="Anticipated">September 9, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 9, 2019</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in weight will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in blood glucose will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in insulin will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in blood pressure will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waistline</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in waistline will be assessed .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IGF-1</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in IGF-1 will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in pulse rate will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood lipid test</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in blood including HDL, LDL, TG, CHO and ect. will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine test</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in urine including uric acid and ect. will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver and renal function test</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in liver and renal function including AST,ALT,ALP, TP,ALB, Urea, Crea and ect will be assessed at 7：30 am.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum metabolomics analysis</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Serum samples were collected and serum metabolomics (carbohydrate, lipid, amino acid and ect.) were sequenced and analyzed by High-throughput sequencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary ketone</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in urinary ketone will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin examination</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in vitamin including vitamin C,D,E and etc. will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid function</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in Thyroid function test including FT3，FT4，TSH will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory factors</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Changes in inflammatory factors includingIL1, IL2, IL6, IL10，TNF ,TGFβ and etc. will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiome</measure>
    <time_frame>Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Stool samples were collected in time if possible and analyzed the composition /function of the intestinal microflora by High-throughput sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rating depression scale；</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>The Scale ,includes half of items ues positive words and half is negatively,which could assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Rating Anxiety Scale；</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>The Scale contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). There are fifteen questions involved in the assessment could indicate the increase of anxiety levels, and rest of the questions assessment would decrease of the anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of anxiety severity: within normal ranger no significant psychopathology (25-49points); presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Scale</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at 1 day、4 day、6 day、9 day、40 day. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at 1 day、4 day、6 day、9 day、40 day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Scale</measure>
    <time_frame>Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting</time_frame>
    <description>Remission according to HAM-D: HAM-D17 score less than or equal to (=&lt;) 7 or a HAM-D7 score =&lt; 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Fasting</condition>
  <arm_group>
    <arm_group_label>prolonged fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants fast for five days, without any food, except unlimited mineral water, and do some fitness regimen(such as meditation and mild physical exercise ).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>prolonged fasting</intervention_name>
    <description>Fasting for 5 days: Fasting with some fitness regimen, such as meditation and mild physical exercise;&#xD;
Feeding for 3 days: Gradually distribute participants with rice flour, porridge and juice.</description>
    <arm_group_label>prolonged fasting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. 18-65 years old, no nationality limitation, no gender limitation;&#xD;
&#xD;
          2. Male weight ≥ 50 kg, female weight ≥ 45 kg；BMI: 19-28 kg/m²;&#xD;
&#xD;
          3. The index of physical examination is in line with health standards;&#xD;
&#xD;
          4. People who have gone through a 7-day fasting before ;&#xD;
&#xD;
          5. Agree to take part in the trials and sign the informed consent form.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. People with unhealthy habits, such as smoking(5 cigarettes per day, or can not stop&#xD;
             smoking in the trial), excessive drinking(drink regularly in the recent 6 months or&#xD;
             more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40%&#xD;
             spirits or 150 ml wine)) ;&#xD;
&#xD;
          2. People who processed fasting within one month;&#xD;
&#xD;
          3. Pregnancy, current breast-feeding or menstrual period;&#xD;
&#xD;
          4. People who are marantic, malnourished or anorectic;&#xD;
&#xD;
          5. People who have cardiovascular disease(coronary heart disease, atherosclerosis,&#xD;
             arrhythmia, etc), serious metabolic and psychiatric disorders(hypertension, type 2&#xD;
             diabetes, hyperthyroidism, etc.);&#xD;
&#xD;
          6. People who have Mental illness, cancer, hepatitis B surface antigen (HBsAg), hepatitis&#xD;
             C virus (HCV), syphilis, human immunodeficiency virus (HIV) antibody positive.&#xD;
&#xD;
          7. people who has mental disorders according to the scales(Hamilton Anxiety&#xD;
             Scale、Self-Rating Anxiety Scale、Self-rating depression scale)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lijun Jia, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prolonged fasting</keyword>
  <keyword>meditation</keyword>
  <keyword>physical exercise</keyword>
  <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/NCT03754920
org study id: ShanghaiUTCMjialijun
nct id: NCT03754920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the feasibility, safety and efficacy of fasting, participants are recruited in a
      5-days fasting ( without any food, except unlimited mineral water),and do some fitness
      regimen (such as meditation and mild physical exercise ) during fasting.The samples will be
      collected from participates and subjected to comprehensive analysis ,including routine
      medical examination in blood, metabonomics and proteomics anlysis in serum and urine samples,
      gut microbiome analysis in stood samples, and so on.
1. Recruiting: 45 healthy people will be included in the clinical trial according to the
           Inclusion criteria and exclusion criteria.

        2. Fasting : Participants fast for five days, without any food, except unlimited mineral
           water. Participants will do some fitness regimen (such as meditation and mild physical
           exercise ) during fasting.

        3. Re-feeding: Gradually distribute participants with rice flour, porridge and juice in the
           next 3 days.

        4. Follow-up :The health checklist is similar with that during fasting on the first month.

        5. Data processing, statistics and analysis. Diet monitoring: The intake of glucose
           decreases, while the burning of fat increases, which can down-regulate glucose level in
           blood, up-regulate ketone level in urine. Thus, the fasting situation of participants
           can be monitored by the variation of blood glucose and urine ketone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Weight
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in weight will be assessed.
measure: Blood glucose
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in blood glucose will be assessed.
measure: Insulin
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in insulin will be assessed.
measure: Blood pressure
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in blood pressure will be assessed.
measure: Waistline
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in waistline will be assessed .
measure: IGF-1
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in IGF-1 will be assessed.
measure: Pulse Rate
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in pulse rate will be assessed.
measure: Blood lipid test
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in blood including HDL, LDL, TG, CHO and ect. will be assessed.
measure: Urine test
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in urine including uric acid and ect. will be assessed.
measure: Liver and renal function test
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in liver and renal function including AST,ALT,ALP, TP,ALB, Urea, Crea and ect will be assessed at 7：30 am.
measure: Serum metabolomics analysis
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Serum samples were collected and serum metabolomics (carbohydrate, lipid, amino acid and ect.) were sequenced and analyzed by High-throughput sequencing.
measure: Urinary ketone
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Changes in urinary ketone will be assessed.
measure: Vitamin examination
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in vitamin including vitamin C,D,E and etc. will be assessed.
measure: Thyroid function
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in Thyroid function test including FT3，FT4，TSH will be assessed.
measure: Inflammatory factors
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Changes in inflammatory factors includingIL1, IL2, IL6, IL10，TNF ,TGFβ and etc. will be assessed.
measure: Gut microbiome
time frame: Day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8; 1 month and 3 months post fasting
description: Stool samples were collected in time if possible and analyzed the composition /function of the intestinal microflora by High-throughput sequencing
measure: Self-rating depression scale；
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: The Scale ,includes half of items ues positive words and half is negatively,which could assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).
measure: Self-Rating Anxiety Scale；
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: The Scale contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). There are fifteen questions involved in the assessment could indicate the increase of anxiety levels, and rest of the questions assessment would decrease of the anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The scale standard scores were used to define four categories of anxiety severity: within normal ranger no significant psychopathology (25-49points); presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).
measure: Hamilton Anxiety Scale
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at 1 day、4 day、6 day、9 day、40 day. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at 1 day、4 day、6 day、9 day、40 day.
measure: Hamilton Depression Scale
time frame: Day 0, day 3, day 5, day 8; 1 month and 3 months post fasting
description: Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.
arm group label: prolonged fasting
arm group type: Experimental
description: Participants fast for five days, without any food, except unlimited mineral water, and do some fitness regimen(such as meditation and mild physical exercise ).
intervention type: Behavioral
intervention name: prolonged fasting
description: Fasting for 5 days: Fasting with some fitness regimen, such as meditation and mild physical exercise;
Feeding for 3 days: Gradually distribute participants with rice flour, porridge and juice.
arm group label: prolonged fasting
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lijun Jia, Ph.D.
role: Principal Investigator
affiliation: Shanghai University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided