Modified Intermittent Fasting in Psoriasis

NCT ID: NCT04418791

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-17
• Study Completion Date: 2022-02-23

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).

Conditions

Psoriasis Vulgaris; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MIF-regular

MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.

Group Type: EXPERIMENTAL

Modified Intermittent Fasting followed by Regular Diet

Intervention Type: BEHAVIORAL

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-MIF

Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.

Group Type: EXPERIMENTAL

Regular Diet followed by Modified Intermittent Fasting

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Lambert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Department of Head & Skin

Ghent, East-Flanders, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 35195533 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/35195533/

Related Info

Other Identifiers

BC-6977

Identifier Type: -

Identifier Source: org_study_id