Modified Intermittent Fasting in Psoriasis

NCT04418791 | Completed

• 1 other identifier: BC-6977
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris; Psoriasis

Keywords

Psoriasis; Fasting; Modified intermittent fasting; Leaky gut; Intestinal barrier

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Total body fat during and after intervention to baseline

  12 and 26 weeks

• Weight during and after intervention to baseline

  12 and 26 weeks

• Body Mass Index during and after intervention to baseline

  12 and 26 weeks

• Waist circumference during and after intervention to baseline

  12 and 26 weeks

• Inflammation markers in serum during and after intervention to baseline

  12 and 26 weeks

Study Arms (2)

MIF-regular

EXPERIMENTAL

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

Regular-MIF

EXPERIMENTAL

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

Interventions

Modified Intermittent Fasting followed by Regular Diet 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.

MIF-regular

Regular Diet followed by Modified Intermittent Fasting 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).

Regular-MIF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Department of Head & Skin

Ghent, East-Flanders, 9000, Belgium

Location

Related 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: 10.2196/26405.

  PMID: 35195533 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis; Fasting

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Study Officials

• Jo Lambert, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Skin severity will be assessed by blinded physician for quantification of Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: June 5, 2020
• Study Start: October 17, 2020
• Primary Completion: June 30, 2021
• Study Completion: February 23, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)