Psoriasis, Psoriasis Vulgaris
Conditions
Keywords
Psoriasis, Fasting, Modified intermittent fasting, Leaky gut, Intestinal barrier
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).
Interventions
BEHAVIORALModified Intermittent Fasting followed by Regular Diet
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.
BEHAVIORALRegular Diet followed by Modified Intermittent Fasting
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).
Sponsors
University Ghent
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index | 12 and 26 weeks | Change in Psoriasis Area Severity Index |
| Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area | 12 and 26 weeks | Change in Body Surface Area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index during and after intervention to baseline | 12 and 26 weeks | Change in Body Mass Index measured as weight (kg) and height (m) (kg/m\^2) |
| Waist circumference during and after intervention to baseline | 12 and 26 weeks | Change in waist circumference (cm) |
| Inflammation markers in serum during and after intervention to baseline | 12 and 26 weeks | Change in serological markers for inflammation \[pg/ml\] |
| Inflammation markers in skin during and after intervention to baseline | 12 and 26 weeks | Change in cutaneous markers for inflammation \[pg/ml\] |
| Metabolic markers in serum during and after intervention to baseline | 12 and 26 weeks | Change in serological markers for metabolism \[pg/ml\] |
| Metabolic markers in skin during and after intervention to baseline | 12 and 26 weeks | Change in cutaneous markers for metabolism \[pg/ml\] |
| Total body fat during and after intervention to baseline | 12 and 26 weeks | Change in total body fat |
| Permeability markers in feces during and after intervention to baseline | 12 and 26 weeks | Change in fecal markers for permeability \[pg/ml\] |
| Visual Analogue Scale Satisfaction | 12 and 26 weeks | 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 | 12 and 26 weeks | Number of subjects who completed the study successfully (adherence to intervention) as a percentage. |
| Quality of life during and after intervention to baseline | 12 and 26 weeks | Change in Dermatology Life Quality Index (absolute and relative) |
| Prediction of dietary intake | 12 and 26 weeks | Correlation of outcomes 1-15 in relation to dietary intake |
| Permeability markers in serum during and after intervention to baseline | 12 and 26 weeks | Change in serological markers for permeability \[pg/ml\] |
| Weight during and after intervention to baseline | 12 and 26 weeks | Change in weight (kg) |
Countries
Belgium
Outcome results
None listed