Modified Intermittent Fasting in Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis; Psoriasis Vulgaris
• Interventions: Behavioral: Modified Intermittent Fasting followed by Regular Diet; Behavioral: Regular Diet followed by Modified Intermittent Fasting

• Registration Number: NCT04418791
• Lead Sponsor: University Hospital, Ghent

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).

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Study Start: 2020-10-17
• Primary Completion: 2021-06-30
• Study Completion: 2022-02-23
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MIF-regular	Modified Intermittent Fasting followed by Regular Diet	MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.
Regular-MIF	Regular Diet followed by Modified Intermittent Fasting	Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Weight during and after intervention to baseline	12 and 26 weeks	Change in weight (kg)
Total body fat during and after intervention to baseline	12 and 26 weeks	Change in total body fat
Metabolic markers in skin during and after intervention to baseline	12 and 26 weeks	Change in cutaneous markers for metabolism \[pg/ml\]
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 \[pg/ml\]
Permeability markers in serum during and after intervention to baseline	12 and 26 weeks	Change in serological markers for permeability \[pg/ml\]
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

Trial Locations

Locations (1)

Department of Head & Skin; 🇧🇪 Ghent, East-Flanders, Belgium