<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/NCT03785197</url>
  </required_header>
  <id_info>
    <org_study_id>FASTA</org_study_id>
    <nct_id>NCT03785197</nct_id>
  </id_info>
  <brief_title>Effects of a Clinical Dietary Intervention During Inpatient Treatment</brief_title>
  <acronym>FASTA</acronym>
  <official_title>Effects of a Clinical Dietary Intervention During Inpatient Treatment (Modified Fasting in Metabolic Syndrome, Osteoarthritis of the Hip or Knee, Rheumatoid Arthritis and Fibromyalgia)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      The purpose of the study is a scientific and prospective documentation of the clinical&#xD;
      effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for&#xD;
      complementary and integrative medicine, with the use of a modified fasting regime. A pre- and&#xD;
      post- as well as group comparisons are planned. Patients that are admitted to the inpatient&#xD;
      department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis&#xD;
      and fibromyalgia will be enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the beginning, during and at the end of the treatment at the inpatient department routine&#xD;
      blood parameters, anthropometric parameters and certain scores and parameters specific to the&#xD;
      different conditions will be measured. Questionnaires will be filled out by patients before&#xD;
      and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity Score 28 (DAS 28)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire with Clinical Examination; Change from Baseline in the DAS-28, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire consisting of 24 items divided into 3 subscales: Pain (5items), Stiffness (2 items), Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).&#xD;
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher values meaning a higher grade of disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Diabetes Self Care Activities Measure (SDSCA)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; 11 items with each item scored on a scale of 0-7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain on Visual Analogue Scale (VAS)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; Change from Baseline in the PSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 &amp; 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (WHO-5)</measure>
    <time_frame>Change Baseline, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body-Mass-Index (BMI)</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Anthropometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Measuring systolic and diastolic blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24h-Blood pressure</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Measuring systolic and diastolic blood pressure with Device &quot;Mobil-O-Graph&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood count</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Laboratory test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular filtration rate (GFR)</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Laboratory test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>CRP in milligram per liter (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver enzymes (GOT, GPT)</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>Hepatic transaminases (GPT, GOT in U/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stepcounter</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>With Device &quot;Everion&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>With Device &quot;Faros 180&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>With Device &quot;Everion&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Oxygenation</measure>
    <time_frame>Change Baseline, 2 weeks</time_frame>
    <description>With Device &quot;Everion&quot;</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Fibromyalgia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prolonged modified fasting</intervention_name>
    <description>The prolonged modified fasting is a dietary intervention with abstinence from solid foods and a caloric intake of 100-400 kcal through juices and vegetable broths</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, serum, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Regular hospitalised patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is consents to participating in the trial during the first 24h of his or&#xD;
             her stay in the inpatient naturopathic department of the Immanuel Hospital.&#xD;
&#xD;
          -  Written informed consent is given&#xD;
&#xD;
          -  The referral diagnosis is one of the following: diabetes mellitus type 2/metabolic&#xD;
             syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis,&#xD;
             fibromyalgia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Language barries to understanding the instructions of the study personnel&#xD;
&#xD;
          -  Dementia or other strong cognitive impairment&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Taking part in another study at the same time&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Immanuel Hospital</name>
      <address>
        <city>Berlin-Wannsee</city>
        <state>Berlin</state>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>fasting</keyword>
  <keyword>natural therapies</keyword>
  <keyword>prolonged fasting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03785197
org study id: FASTA
nct id: NCT03785197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is a scientific and prospective documentation of the clinical
      effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for
      complementary and integrative medicine, with the use of a modified fasting regime. A pre- and
      post- as well as group comparisons are planned. Patients that are admitted to the inpatient
      department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis
      and fibromyalgia will be enrolled in the study.
At the beginning, during and at the end of the treatment at the inpatient department routine
      blood parameters, anthropometric parameters and certain scores and parameters specific to the
      different conditions will be measured. Questionnaires will be filled out by patients before
      and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.
observational model: Cohort
time perspective: Prospective
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
measure: Disease Activity Score 28 (DAS 28)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire with Clinical Examination; Change from Baseline in the DAS-28, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission
measure: Health Assessment Questionnaire (HAQ)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire consisting of 24 items divided into 3 subscales: Pain (5items), Stiffness (2 items), Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher values meaning a higher grade of disability.
measure: Summary of Diabetes Self Care Activities Measure (SDSCA)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; 11 items with each item scored on a scale of 0-7.
measure: Pain on Visual Analogue Scale (VAS)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome
measure: Perceived Stress Scale (PSS)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; Change from Baseline in the PSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
measure: Quality of Life (WHO-5)
time frame: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
description: Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
measure: Body-Mass-Index (BMI)
time frame: Change Baseline, 2 weeks
description: Anthropometry
measure: Blood pressure
time frame: Change Baseline, 2 weeks
description: Measuring systolic and diastolic blood pressure in mmHg
measure: 24h-Blood pressure
time frame: Change Baseline, 2 weeks
description: Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"
measure: Blood count
time frame: Change Baseline, 2 weeks
description: Laboratory test
measure: Glomerular filtration rate (GFR)
time frame: Change Baseline, 2 weeks
description: Laboratory test
measure: Blood lipids
time frame: Change Baseline, 2 weeks
description: triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)
measure: CRP
time frame: Change Baseline, 2 weeks
description: CRP in milligram per liter (mg/L)
measure: Liver enzymes (GOT, GPT)
time frame: Change Baseline, 2 weeks
description: Hepatic transaminases (GPT, GOT in U/L)
measure: Stepcounter
time frame: Change Baseline, 2 weeks
description: With Device "Everion"
measure: Heart Rate Variability
time frame: Change Baseline, 2 weeks
description: With Device "Faros 180"
measure: Heart Rate
time frame: Change Baseline, 2 weeks
description: With Device "Everion"
measure: Blood Oxygenation
time frame: Change Baseline, 2 weeks
description: With Device "Everion"
intervention type: Other
intervention name: Prolonged modified fasting
description: The prolonged modified fasting is a dietary intervention with abstinence from solid foods and a caloric intake of 100-400 kcal through juices and vegetable broths
Blood, serum, urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andreas Michalsen, Prof. Dr.
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No