Clinical trial NCT04418791: Modified Intermittent Fasting in Psoriasis
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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Psoriasis
Keywords: Psoriasis
Fasting
Modified intermittent fasting
Leaky gut
Intestinal barrier
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2020-06-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
timeFrame: 12 and 26 weeks
measure: Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
timeFrame: 12 and 26 weeks
Secondary outcomes:
measure: Total body fat during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Weight during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Body Mass Index during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Waist circumference during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Inflammation markers in serum during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Inflammation markers in skin during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Metabolic markers in serum during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Metabolic markers in skin during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Permeability markers in serum during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Permeability markers in feces during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Visual Analogue Scale Satisfaction
timeFrame: 12 and 26 weeks
measure: Study completion by subjects
timeFrame: 12 and 26 weeks
measure: Quality of life during and after intervention to baseline
timeFrame: 12 and 26 weeks
measure: Prediction of dietary intake
timeFrame: 12 and 26 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Head & Skin
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Jo Lambert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.