Clinical Trials Directory

Trials / Completed

CompletedNCT04418791

Modified Intermittent Fasting in Psoriasis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALModified Intermittent Fasting followed by Regular DietModified 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.
BEHAVIORALRegular Diet followed by Modified Intermittent FastingRegular 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).

Timeline

Start date
2020-10-17
Primary completion
2021-06-30
Completion
2022-02-23
First posted
2020-06-05
Last updated
2024-09-19

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04418791. Inclusion in this directory is not an endorsement.