Modified Intermittent Fasting in Psoriasis

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Psoriasis Vulgaris, Psoriasis

Intervention / Treatment
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* Behavioral: Modified Intermittent Fasting followed by Regular Diet
* Behavioral: Regular Diet followed by Modified Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIF-regular<br>MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention. | Behavioral: Modified Intermittent Fasting followed by Regular Diet<br>* 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.<br>|
| Experimental: Regular-MIF<br>Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting. | Behavioral: Regular Diet followed by Modified Intermittent Fasting<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index | Change in Psoriasis Area Severity Index | 12 and 26 weeks | 
| Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area | Change in Body Surface Area | 12 and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body fat during and after intervention to baseline | Change in total body fat | 12 and 26 weeks | 
| Weight during and after intervention to baseline | Change in weight (kg) | 12 and 26 weeks | 
| Body Mass Index during and after intervention to baseline | Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2) | 12 and 26 weeks | 
| Waist circumference during and after intervention to baseline | Change in waist circumference (cm) | 12 and 26 weeks | 
| Inflammation markers in serum during and after intervention to baseline | Change in serological markers for inflammation [pg/ml] | 12 and 26 weeks | 
| Inflammation markers in skin during and after intervention to baseline | Change in cutaneous markers for inflammation [pg/ml] | 12 and 26 weeks | 
| Metabolic markers in serum during and after intervention to baseline | Change in serological markers for metabolism [pg/ml] | 12 and 26 weeks | 
| Metabolic markers in skin during and after intervention to baseline | Change in cutaneous markers for metabolism [pg/ml] | 12 and 26 weeks | 
| Permeability markers in serum during and after intervention to baseline | Change in serological markers for permeability [pg/ml] | 12 and 26 weeks | 
| Permeability markers in feces during and after intervention to baseline | Change in fecal markers for permeability [pg/ml] | 12 and 26 weeks | 
| 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) | 12 and 26 weeks | 
| Study completion by subjects | Number of subjects who completed the study successfully (adherence to intervention) as a percentage. | 12 and 26 weeks | 
| Quality of life during and after intervention to baseline | Change in Dermatology Life Quality Index (absolute and relative) | 12 and 26 weeks | 
| Prediction of dietary intake | Correlation of outcomes 1-15 in relation to dietary intake | 12 and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leaky gut, Psoriasis, Fasting, Modified intermittent fasting, Intestinal barrier