Modified Intermittent Fasting in Psoriasis (MANGO)
Primary Purpose
Psoriasis Vulgaris, Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Modified Intermittent Fasting followed by Regular Diet
Regular Diet followed by Modified Intermittent Fasting
Sponsored by

About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis, Fasting, Modified intermittent fasting, Leaky gut, Intestinal barrier
Eligibility Criteria
Inclusion Criteria:
- Mild psoriasis (PASI < 10)
- At least BMI of 20
- Stable weight for last 3 months
- Topical treatment
- Availability of smartphone and willing to install app
- Willing to attend dematology clinic at Ghent University Hospital
Exclusion Criteria:
- Underweight and/or following strict diet
- Use of anti, pre and/or probiotics (last 3 months)
- Use of immunosuppressants (last 3 months)
- Smoking
- Consumption of fish oil
- Diagnosed diabetes (type ½)
- Excessive physical activity
- Pregnancy or breastfeeding
- More than 14 alcohol units/week
- History of cardiac condition(s)
Sites / Locations
- Department of Head & Skin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MIF-regular
Regular-MIF
Arm Description
MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.
Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.
Outcomes
Primary Outcome Measures
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
Change in Psoriasis Area Severity Index
Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
Change in Body Surface Area
Secondary Outcome Measures
Total body fat during and after intervention to baseline
Change in total body fat
Weight during and after intervention to baseline
Change in weight (kg)
Body Mass Index during and after intervention to baseline
Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)
Waist circumference during and after intervention to baseline
Change in waist circumference (cm)
Inflammation markers in serum during and after intervention to baseline
Change in serological markers for inflammation [pg/ml]
Inflammation markers in skin during and after intervention to baseline
Change in cutaneous markers for inflammation [pg/ml]
Metabolic markers in serum during and after intervention to baseline
Change in serological markers for metabolism [pg/ml]
Metabolic markers in skin during and after intervention to baseline
Change in cutaneous markers for metabolism [pg/ml]
Permeability markers in serum during and after intervention to baseline
Change in serological markers for permeability [pg/ml]
Permeability markers in feces during and after intervention to baseline
Change in fecal markers for permeability [pg/ml]
Visual Analogue Scale Satisfaction
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)
Study completion by subjects
Number of subjects who completed the study successfully (adherence to intervention) as a percentage.
Quality of life during and after intervention to baseline
Change in Dermatology Life Quality Index (absolute and relative)
Prediction of dietary intake
Correlation of outcomes 1-15 in relation to dietary intake
Full Information
NCT ID
NCT04418791
First Posted
December 18, 2019
Last Updated
December 20, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04418791
Brief Title
Modified Intermittent Fasting in Psoriasis
Acronym
MANGO
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
February 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Psoriasis
Keywords
Psoriasis, Fasting, Modified intermittent fasting, Leaky gut, Intestinal barrier
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
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)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIF-regular
Arm Type
Experimental
Arm Description
MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.
Arm Title
Regular-MIF
Arm Type
Experimental
Arm 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(s)
Modified Intermittent Fasting followed by Regular Diet
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Regular Diet followed by Modified Intermittent Fasting
Intervention 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).
Primary Outcome Measure Information:
Title
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
Description
Change in Psoriasis Area Severity Index
Time Frame
12 and 26 weeks
Title
Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
Description
Change in Body Surface Area
Time Frame
12 and 26 weeks
Secondary Outcome Measure Information:
Title
Total body fat during and after intervention to baseline
Description
Change in total body fat
Time Frame
12 and 26 weeks
Title
Weight during and after intervention to baseline
Description
Change in weight (kg)
Time Frame
12 and 26 weeks
Title
Body Mass Index during and after intervention to baseline
Description
Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)
Time Frame
12 and 26 weeks
Title
Waist circumference during and after intervention to baseline
Description
Change in waist circumference (cm)
Time Frame
12 and 26 weeks
Title
Inflammation markers in serum during and after intervention to baseline
Description
Change in serological markers for inflammation [pg/ml]
Time Frame
12 and 26 weeks
Title
Inflammation markers in skin during and after intervention to baseline
Description
Change in cutaneous markers for inflammation [pg/ml]
Time Frame
12 and 26 weeks
Title
Metabolic markers in serum during and after intervention to baseline
Description
Change in serological markers for metabolism [pg/ml]
Time Frame
12 and 26 weeks
Title
Metabolic markers in skin during and after intervention to baseline
Description
Change in cutaneous markers for metabolism [pg/ml]
Time Frame
12 and 26 weeks
Title
Permeability markers in serum during and after intervention to baseline
Description
Change in serological markers for permeability [pg/ml]
Time Frame
12 and 26 weeks
Title
Permeability markers in feces during and after intervention to baseline
Description
Change in fecal markers for permeability [pg/ml]
Time Frame
12 and 26 weeks
Title
Visual Analogue Scale Satisfaction
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)
Time Frame
12 and 26 weeks
Title
Study completion by subjects
Description
Number of subjects who completed the study successfully (adherence to intervention) as a percentage.
Time Frame
12 and 26 weeks
Title
Quality of life during and after intervention to baseline
Description
Change in Dermatology Life Quality Index (absolute and relative)
Time Frame
12 and 26 weeks
Title
Prediction of dietary intake
Description
Correlation of outcomes 1-15 in relation to dietary intake
Time Frame
12 and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild psoriasis (PASI < 10)
At least BMI of 20
Stable weight for last 3 months
Topical treatment
Availability of smartphone and willing to install app
Willing to attend dematology clinic at Ghent University Hospital
Exclusion Criteria:
Underweight and/or following strict diet
Use of anti, pre and/or probiotics (last 3 months)
Use of immunosuppressants (last 3 months)
Smoking
Consumption of fish oil
Diagnosed diabetes (type ½)
Excessive physical activity
Pregnancy or breastfeeding
More than 14 alcohol units/week
History of cardiac condition(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Head & Skin
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35195533
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35195533/
Description
Related Info
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Modified Intermittent Fasting in Psoriasis
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