Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 10, 2020
Date Accepted: Dec 18, 2020
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Modified Intermittent Fasting in Psoriasis (MANGO) trial: a two-arm pilot randomized controlled open cross-over study
ABSTRACT
Background:
Psoriasis is a complex disease associated with multiple comorbidities, including metabolic syndrome and leaky gut syndrome. Dietary lifestyle interventions have been reported to affect the disease in terms of lesional severity. It remains unclear how diets affect these comorbidities and the general health in psoriasis patients. Modified Intermittent Fasting (MIF) on 2 non-consecutive days has shown beneficial effects on metabolic parameters. A significant advantage of MIF over the currently investigated dietary changes is its feasibility.
Objective:
Here, we aim to study the effects of MIF on skin, gut and metabolic health in psoriasis patients.
Methods:
A two-arm pilot prospective cross-over randomized control trial (RCT) will be performed in 20 patients with psoriasis as a pilot study. Patients will be randomized 1:1 to either start with MIF and subsequent regular diet for 12 weeks each or to start with regular diet and subsequent MIF for 12 weeks each. The following parameters will be assessed: demographics, disease phenotype, medical and familial history, psoriasis severity, dermatology-specific and general quality of life, nutritional and physical habits, mental and intestinal health, intestinal and cutaneous integrity, inflammatory and metabolic markers, and satisfaction.
Results:
The aim is to uncover the effects of MIF on psoriasis severity and gut health integrity through clinical and molecular investigation. More precisely, we want to map the evolution of the different markers in response to MIF as compared to the regular diet, such as psoriasis severity, permeability and inflammation.
Conclusions:
Understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis and may pose a non-pharmacological venue for treatments. Clinical Trial: ClinicalTrials.gov, NCT04418791. Registered June 5 2020, https://clinicaltrials.gov/ct2/show/NCT04418791. Current protocol date/version: May 20 2020
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