Modified Intermittent Fasting in Psoriasis

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418791
• Other study ID #: MANGO
• Status: Completed
• Phase: N/A
• Start date: October 17, 2020
• Est. completion date: February 23, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 23, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Behavioral:
• Modified 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.
• Regular 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).

Locations

Country	Name	City	State
Belgium	Department of Head & Skin	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area	Change in Body Surface Area	12 and 26 weeks
Secondary	Total body fat during and after intervention to baseline	Change in total body fat	12 and 26 weeks
Secondary	Weight during and after intervention to baseline	Change in weight (kg)	12 and 26 weeks
Secondary	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
Secondary	Waist circumference during and after intervention to baseline	Change in waist circumference (cm)	12 and 26 weeks
Secondary	Inflammation markers in serum during and after intervention to baseline	Change in serological markers for inflammation [pg/ml]	12 and 26 weeks
Secondary	Inflammation markers in skin during and after intervention to baseline	Change in cutaneous markers for inflammation [pg/ml]	12 and 26 weeks
Secondary	Metabolic markers in serum during and after intervention to baseline	Change in serological markers for metabolism [pg/ml]	12 and 26 weeks
Secondary	Metabolic markers in skin during and after intervention to baseline	Change in cutaneous markers for metabolism [pg/ml]	12 and 26 weeks
Secondary	Permeability markers in serum during and after intervention to baseline	Change in serological markers for permeability [pg/ml]	12 and 26 weeks
Secondary	Permeability markers in feces during and after intervention to baseline	Change in fecal markers for permeability [pg/ml]	12 and 26 weeks
Secondary	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
Secondary	Study completion by subjects	Number of subjects who completed the study successfully (adherence to intervention) as a percentage.	12 and 26 weeks
Secondary	Quality of life during and after intervention to baseline	Change in Dermatology Life Quality Index (absolute and relative)	12 and 26 weeks
Secondary	Prediction of dietary intake	Correlation of outcomes 1-15 in relation to dietary intake	12 and 26 weeks

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