<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/NCT04418791</url>
  </required_header>
  <id_info>
    <org_study_id>MANGO</org_study_id>
    <nct_id>NCT04418791</nct_id>
  </id_info>
  <brief_title>Modified Intermittent Fasting in Psoriasis</brief_title>
  <acronym>MANGO</acronym>
  <official_title>Modified Intermittent Fasting in Psoriasis Trial: a Randomized Controlled Open Crossover Clinical Trial to Investigate the Effects of a Dietary Intervention on the Gut-skin Axis in Patients With Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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 complexity of psoriasis is partially affected by dietary effects, and some diets have&#xD;
      shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of&#xD;
      these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with&#xD;
      psoriasis have been reported to have impaired intestinal integrity and it has been suggested&#xD;
      that gut health affects skin health, pointing towards a gut-skin axis. Understanding how&#xD;
      dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly&#xD;
      improve our understanding on the development of psoriasis. Modified intermittent fasting&#xD;
      (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect&#xD;
      on gut and skin remains underexplored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study the role of gut health, more specifically the intestinal barrier, in individuals&#xD;
      with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over&#xD;
      study. The investigators will test whether MIF can improve (i) skin lesions (clinical and&#xD;
      molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and&#xD;
      (iii) the timing of these improvements. As such, it can be determined whether fasting&#xD;
      benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal&#xD;
      for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be&#xD;
      tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating&#xD;
      between MIF and usual diet).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2020</start_date>
  <completion_date type="Actual">February 23, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>
    <masking_description>Skin severity will be assessed by blinded physician for quantification of Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in Psoriasis Area Severity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in Body Surface Area</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total body fat during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in total body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation markers in serum during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in serological markers for inflammation [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation markers in skin during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in cutaneous markers for inflammation [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic markers in serum during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in serological markers for metabolism [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic markers in skin during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in cutaneous markers for metabolism [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permeability markers in serum during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in serological markers for permeability [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permeability markers in feces during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in fecal markers for permeability [pg/ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale Satisfaction</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Score of subject's rating of satisfaction and/or feasibility on intervention based on a Visual Analogue Scale going from 0 (not satisfied at all) to 10 (very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study completion by subjects</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Number of subjects who completed the study successfully (adherence to intervention) as a percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life during and after intervention to baseline</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Change in Dermatology Life Quality Index (absolute and relative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction of dietary intake</measure>
    <time_frame>12 and 26 weeks</time_frame>
    <description>Correlation of outcomes 1-15 in relation to dietary intake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>MIF-regular</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular-MIF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified Intermittent Fasting followed by Regular Diet</intervention_name>
    <description>Modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows.</description>
    <arm_group_label>MIF-regular</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular Diet followed by Modified Intermittent Fasting</intervention_name>
    <description>Regular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours).</description>
    <arm_group_label>Regular-MIF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild psoriasis (PASI &lt; 10)&#xD;
&#xD;
          -  At least BMI of 20&#xD;
&#xD;
          -  Stable weight for last 3 months&#xD;
&#xD;
          -  Topical treatment&#xD;
&#xD;
          -  Availability of smartphone and willing to install app&#xD;
&#xD;
          -  Willing to attend dematology clinic at Ghent University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underweight and/or following strict diet&#xD;
&#xD;
          -  Use of anti, pre and/or probiotics (last 3 months)&#xD;
&#xD;
          -  Use of immunosuppressants (last 3 months)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Consumption of fish oil&#xD;
&#xD;
          -  Diagnosed diabetes (type ½)&#xD;
&#xD;
          -  Excessive physical activity&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  More than 14 alcohol units/week&#xD;
&#xD;
          -  History of cardiac condition(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jo Lambert, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Head &amp; Skin</name>
      <address>
        <city>Ghent</city>
        <state>East-Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/35195533/</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Grine L, Hilhorst N, Michels N, Abbeddou S, De Henauw S, Lambert J. The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. JMIR Res Protoc. 2022 Feb 23;11(2):e26405. doi: 10.2196/26405.</citation>
    <PMID>35195533</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 18, 2019</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Fasting</keyword>
  <keyword>Modified intermittent fasting</keyword>
  <keyword>Leaky gut</keyword>
  <keyword>Intestinal barrier</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT04418791
org study id: MANGO
nct id: NCT04418791
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The complexity of psoriasis is partially affected by dietary effects, and some diets have
      shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of
      these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with
      psoriasis have been reported to have impaired intestinal integrity and it has been suggested
      that gut health affects skin health, pointing towards a gut-skin axis. Understanding how
      dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly
      improve our understanding on the development of psoriasis. Modified intermittent fasting
      (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect
      on gut and skin remains underexplored.
To study the role of gut health, more specifically the intestinal barrier, in individuals
      with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over
      study. The investigators will test whether MIF can improve (i) skin lesions (clinical and
      molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and
      (iii) the timing of these improvements. As such, it can be determined whether fasting
      benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal
      for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be
      tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating
      between MIF and usual diet).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Skin severity will be assessed by blinded physician for quantification of Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA)
measure: Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
time frame: 12 and 26 weeks
description: Change in Psoriasis Area Severity Index
measure: Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
time frame: 12 and 26 weeks
description: Change in Body Surface Area
measure: Total body fat during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in total body fat
measure: Weight during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in weight (kg)
measure: Body Mass Index during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)
measure: Waist circumference during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in waist circumference (cm)
measure: Inflammation markers in serum during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in serological markers for inflammation [pg/ml]
measure: Inflammation markers in skin during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in cutaneous markers for inflammation [pg/ml]
measure: Metabolic markers in serum during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in serological markers for metabolism [pg/ml]
measure: Metabolic markers in skin during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in cutaneous markers for metabolism [pg/ml]
measure: Permeability markers in serum during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in serological markers for permeability [pg/ml]
measure: Permeability markers in feces during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in fecal markers for permeability [pg/ml]
measure: Visual Analogue Scale Satisfaction
time frame: 12 and 26 weeks
description: Score of subject's rating of satisfaction and/or feasibility on intervention based on a Visual Analogue Scale going from 0 (not satisfied at all) to 10 (very satisfied)
measure: Study completion by subjects
time frame: 12 and 26 weeks
description: Number of subjects who completed the study successfully (adherence to intervention) as a percentage.
measure: Quality of life during and after intervention to baseline
time frame: 12 and 26 weeks
description: Change in Dermatology Life Quality Index (absolute and relative)
measure: Prediction of dietary intake
time frame: 12 and 26 weeks
description: Correlation of outcomes 1-15 in relation to dietary intake
arm group label: MIF-regular
arm group type: Experimental
description: MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.
arm group label: Regular-MIF
arm group type: Experimental
description: Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.
intervention type: Behavioral
intervention name: Modified Intermittent Fasting followed by Regular Diet
description: Modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows.
arm group label: MIF-regular
intervention type: Behavioral
intervention name: Regular Diet followed by Modified Intermittent Fasting
description: Regular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours).
arm group label: Regular-MIF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jo Lambert, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
country: Belgium
url: https://pubmed.ncbi.nlm.nih.gov/35195533/
description: Related Info
citation: Grine L, Hilhorst N, Michels N, Abbeddou S, De Henauw S, Lambert J. The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. JMIR Res Protoc. 2022 Feb 23;11(2):e26405. doi: 10.2196/26405.
PMID: 35195533
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No