Modified Intermittent Fasting in Psoriasis (MANGO)

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriasis Vulgaris
• Intervention / Treatment: Behavioral: Modified Intermittent Fasting followed by Regular Diet; Behavioral: Regular Diet followed by Modified Intermittent Fasting

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lynda Grine, PhD; Phone Number: 003293322287; Email: lynda.grine@uzgent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Department of Head & Skin
      • Contact: Lynda Grine, PhD; Phone Number: 003293322287; Email: lynda.grine@uzgent.be
      • Principal Investigator: Jo Lambert, MD, PhD
      • Sub-Investigator: Lynda Grine, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIF-regular; 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; 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.
Experimental: Regular-MIF; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Jo Lambert, MD, PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Psoriasis; Fasting; Leaky gut; Modified intermittent fasting; Intestinal barrier
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: MANGO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No