Role of Intermittent Fasting in Psoriasis and Psoriatic Arthritis

March 31, 2026 updated by: Ben H Kaffenberger, Ohio State University

Role of Intermittent Fasting on Disease Severity and Quality of Life in Psoriasis and Psoriatic Arthritis

Our study aims to determine whether intermittent fasting (IMF) is a valid method to improve psoriasis and psoriatic arthritis (PsA) disease severity and quality of life. Patients within OSU Dermatology with psoriasis and/or psoriatic arthritis will be enrolled in a dietary intervention for a 24-week period. A prospective, single-blind parallel group randomized control trial will include an IMF dietary intervention group and a standard routine diet group for a duration of 24 weeks. After the initial 12 weeks of the dietary intervention, patients will be followed for an additional 12 weeks to assess changes in their disease state and quality of life after returning to their initial dietary routines. In total, the study will be 24 weeks. Baseline assessment will consist of standard psoriasis and PsA clinical parameters; evaluation will be performed by a blinded physician. These parameters will be reassessed every 4 weeks via video visit for the three month duration of the study, and then again at the 24-week conclusion of the study. In addition, each visit will assess patient-reported outcomes using dermatology-specific quality of life indices. Biometric measurements of weight, height, BMI, and waist-to-hip ratio will be recorded at baseline and all subsequent visits. Dietary adherence will be assessed by virtual check-in visits, and dietary guidance will be provided and reviewed at each visit by the research coordinator. A physician or the research coordinator will be available for questions between times of data collection. The primary outcome measure will be feasibility of a larger study, which will be determined at the initial 12-week timepoint. This data is vital to determine effect size and dropout frequency for future studies. Secondary outcomes will include changes in clinical indices, biometric measurements, and quality of life indices at 12 weeks after randomization and at the end of the 24-week study. Achievement of a 5% weight reduction at 12 weeks, and a 10-15% weight reduction at 24 weeks will be additional secondary endpoints. Data for each patient will be stored in a password-protected and encrypted REDCAP database on a secure OSU server.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Assess the feasibility of a larger study testing the association between intermittent fasting and disease severity in patients with psoriasis using psoriasis-specific clinical indices and patient-reported psoriasis outcomes.

The investigators will conduct a prospective, single-blind parallel group randomized control trial. Participants will be identified through an electronic medical record search for established patients within the Ohio State Dermatology practice with a diagnosis of mild-to-moderate psoriasis. Patients will then be asked to join the study and subsequently given information to consent. Patients in the control group will be offered entry into the intermittent fasting group after the commencement of the study as an incentive to participate.

Setting: The clinical setting will be the outpatient dermatology clinic sites for the Ohio State University Wexner Medical Center, Columbus, OH. The sites have access to measurement equipment, well-lit examination rooms, clinical trial support, and convenient locations for patient access.

Study Procedures: Patients will receive information regarding their dietary modifications before the start of the study; they will also be randomized to their group at this time. In the IMF group of the study, subjects will be permitted to eat food of any type and quantity for 8 hours of each day at any timing. Patients in the standard routine dietary guidance group are encouraged to continue their current diet while recording their first and last meal of the day until the first data collection. By doing this, the investigators will ensure that there is a difference in total energy consumption time between the IMF group and our controls. After the first 12 weeks of the study and subsequent data collection, patients will be permitted to resume their normal dietary habits for the remaining 12 weeks of the study.

Random Allocation: Following consent, the participants who meet the inclusion criteria will be block randomized by presence of PsA and time in a 1:1 ratio to either the IMF diet intervention or standard routine dietary guidance. Recruitment will ensure at least 20% of each group contains patients with PsA. The assessing physician investigator will be blinded to the group assignment of each patient, although the research coordinator will not be blinded. Patients cannot reasonably be blinded to their assignment. Data for each patient will be stored in a password-protected and encrypted REDCAP database on a secure OSU server. Each patient will receive a random numerical identity in the database which their data points will be associated with. Data access is role-based and limited to PI, research coordinator, statistician, and support staff.

Early stopping rules: Early stop permitted due to illness or lack of adherence; data will be included under the intention-to-treat (ITT) assumption.

Monitoring Plan: Safety monitoring will be patient-reported when patients come to clinical site and in between checkpoints if needed. Due to COVID-19, adjustments for electronic visitations will be allowable if patients can appropriately document all areas of involvement as well as take updated biometric measurements.

Aim 2: Assess the feasibility of a larger study testing the association between intermittent fasting and disease severity in patients with psoriatic arthritis using standardized DAPSA score and patient-reported outcomes

Setting: As in Aim 1, the clinical setting will be the outpatient dermatology clinic sites for the Ohio State University Wexner Medical Center, Columbus, OH. The resources and personnel at these sites are also appropriate for this aim. Design: In this aim, data points to be collected will be the DAPSA score, as well as scoring systems for enthesitis and dactylitis. Quality of life will be assessed using HRQL score.

Study Procedures: After the patient has consented, the patient will be block randomized as in Aim 1. Initial baseline assessment will be performed by a blinded physician. Baseline assessment will consist of DAPSA, enthesitis, and dactylitis indices. Health-related quality of life (HRQL) survey will be administered to patients at baseline and 12 and 24-week timepoints. All other items that are collected in Aim 1 will also be collected in this group.

All other aspects of Aim 2 not mentioned in this section are the same as in Aim 1.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43201
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age and older
  • Established patient at the clinical site with a diagnosis of mild to moderate plaque psoriasis despite treatment
  • Ability to consent and follow dietary instructions
  • Overweight (BMI ≥ 25)
  • No change in systemic psoriasis treatment for 6 weeks

Exclusion Criteria:

  • Pregnancy and/or breastfeeding
  • Insulin-dependent diabetics
  • Severe heart, kidney, and liver disease
  • Obesity due to medical condition
  • Use of medical treatment for weight reduction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent Fasting Group
Patients in this group will do intermittent fasting dieting for 12 weeks, meaning they will only eat for 8 hours per day. They may choose whichever 8 hours they want. Only water can be consumed during the fasting period. For the last 12 weeks of the study, they will resume their normal diet.
Behavioral: Intermittent Fasting Diet
Patients will follow the 16: 8 traditional intermittent fasting model, where they may only consume calories during 1 continuous 8-hour period of the day. Water may be consumed during fasting.
Other Names:
  • fasting
  • intermittent energy restriction
No Intervention: Standard Routine Diet Group
Patients will continue with their normal diets for the 24 week duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease activity (skin) by PASI scoring
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks

Measured by Psoriasis Area Severity Index (PASI; scored 0-72, 72 is worst).

*Note: calculated for both psoriasis and psoriatic arthritis patients.

This score is a calculation based on assessment of erythema, desquamation, and induration in four distinct body areas: head/neck, trunk, upper extremities, and lower extremities.
0 weeks (baseline), 12 weeks, 24 weeks
Change in Disease activity (joints) by PsARC scoring
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks

PsARC (Psoriatic Arthritis Response Criteria)

*Note: only for psoriatic arthritis patients

Response is defined by improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures:

  1. Patient generalized assessment (PGA) of articular disease (0-4, 4 being most severe)

  2. Investigator generalized assessment (IGA) of articular disease (0-4, 4 being most severe)

    *for 1-2: improvement = decrease by one category, worsening = increase by one category.

  3. Joint pain/tenderness score (numeric sum of number of involved joints)
  4. Joint swelling score (numeric sum of number of involved joints) *for 3-4: improvement = decrease by 30%, worsening = increase by 30%.
0 weeks (baseline), 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of skin involvement
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Body surface area (0-100%)
0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (overall)
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Physician's Global Assessment (score 0-4, 4 being worst)
0 weeks (baseline), 12 weeks, 24 weeks
Enthesitis and Dactylitis Assessment
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Will be scored on presence/absence of dactylitis and enthesitis based on physical exam.
0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (nails)
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks

Nail Psoriasis Severity Index (NAPSI; 0-160, 160 is worst) The nail is divided into quadrants, and each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of the following features of nail psoriasis in that quadrant.

  1. Evaluation 1: Nail matrix. In each quadrant of the nail, nail matrix psoriasis is evaluated by presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail.
  2. Evaluation 2: Nail bed. Nail bed psoriasis is evaluated by the presence of any of the nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma): 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants,3 for 3 quadrants, and 4 for 4 quadrants.
  3. Each nail gets a matrix score and
0 weeks (baseline), 12 weeks, 24 weeks
Weight
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Weight will be obtained in kilograms using traditional clinical scale.
0 weeks (baseline), 12 weeks, 24 weeks
Height
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Height will be obtained in meters using traditional clinical scale.
0 weeks (baseline), 12 weeks, 24 weeks
Body Mass Index (BMI)
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
BMI assessed by obtaining weight (kg) and height (m) from traditional clinical scale and calculating.
0 weeks (baseline), 12 weeks, 24 weeks
Waist-to-hip ratio
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks
Waist-to-hip ratio will be measured using tape measure in centimeters and reported as a ratio.
0 weeks (baseline), 12 weeks, 24 weeks
Patient Quality of life (Patient experience with their disease) by DLQI scoring
Time Frame: 0 weeks (baseline), 12 weeks, 24 weeks

Psoriasis: quality of life assessed via Dermatology Life Quality Index (DLQI; scored 0-30, 30 is worst). Psoriatic arthritis: quality of life assessed via Health-related Quality of Life Index (HRQL).

*Note: patients with psoriatic arthritis will complete both surveys.
0 weeks (baseline), 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Psoriasis Foundation

Investigators

  • Principal Investigator: Benjamin H Kaffenberger, MD, MS, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2022

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

December 11, 2025

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022H0186

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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