PsoriasisNCT05590247
Role of Intermittent Fasting in Psoriasis and Psoriatic Arthritis
A study testing Intermittent Fasting Diet in people with Psoriasis and Psoriatic Arthritis, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- Intermittent Fasting Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- Intermittent Fasting Diet
- Keywords
- fasting, intermittent
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Fasting DietBehavioural
Also called fasting, intermittent energy restriction
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting Group | Experimental | 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. Receives: Behavioral: Intermittent Fasting Diet |
| Standard Routine Diet Group | No intervention | Patients will continue with their normal diets for the 24 week duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease activity (skin) by PASI scoring
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.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Change in Disease activity (joints) by PsARC scoring
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:
- Patient generalized assessment (PGA) of articular disease (0-4, 4 being most severe)
- 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.
- Joint pain/tenderness score (numeric sum of number of involved joints)
- Joint swelling score (numeric sum of number of involved joints) *for 3-4: improvement = decrease by 30%, worsening = increase by 30%.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Secondary outcomes (9)
Patient Quality of life (Patient experience with their disease) by DLQI scoring
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.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Amount of skin involvement
Body surface area (0-100%)
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (overall)
Physician's Global Assessment (score 0-4, 4 being worst)
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Enthesitis and Dactylitis Assessment
Will be scored on presence/absence of dactylitis and enthesitis based on physical exam.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (nails)
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.
- 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.
- 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.
- Each nail gets a matrix score and
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Weight
Weight will be obtained in kilograms using traditional clinical scale.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Height
Height will be obtained in meters using traditional clinical scale.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Body Mass Index (BMI)
BMI assessed by obtaining weight (kg) and height (m) from traditional clinical scale and calculating.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Waist-to-hip ratio
Waist-to-hip ratio will be measured using tape measure in centimeters and reported as a ratio.
Measured: 0 weeks (baseline), 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start21 Jul 2022
- Primary completion1 Mar 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Principal investigator, Ben H Kaffenberger, Ohio State University
- Investigators
- Benjamin H Kaffenberger, MD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590247
- Sponsor's protocol ID
- 2022H0186
- Status last verified
- Mar 2026
- First submitted
- 5 Oct 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damiani G, Watad A, Bridgewood C, Pigatto PDM, Pacifico A, Malagoli P, Bragazzi NL, Adawi M. The Impact of Ramadan Fasting on the Reduction of PASI Score, in Moderate-To-Severe Psoriatic Patients: A Real-Life Multicenter Study. Nutrients. 2019 Jan 27;11(2):277. doi: 10.3390/nu11020277.
PubMed 30691245Ford AR, Siegel M, Bagel J, Cordoro KM, Garg A, Gottlieb A, Green LJ, Gudjonsson JE, Koo J, Lebwohl M, Liao W, Mandelin AM 2nd, Markenson JA, Mehta N, Merola JF, Prussick R, Ryan C, Schwartzman S, Siegel EL, Van Voorhees AS, Wu JJ, Armstrong AW. Dietary Recommendations for Adults With Psoriasis or Psoriatic Arthritis From the Medical Board of the National Psoriasis Foundation: A Systematic Review. JAMA Dermatol. 2018 Aug 1;154(8):934-950. doi: 10.1001/jamadermatol.2018.1412.
PubMed 29926091Di Minno MN, Peluso R, Iervolino S, Russolillo A, Lupoli R, Scarpa R; CaRRDs Study Group. Weight loss and achievement of minimal disease activity in patients with psoriatic arthritis starting treatment with tumour necrosis factor alpha blockers. Ann Rheum Dis. 2014 Jun;73(6):1157-62. doi: 10.1136/annrheumdis-2012-202812. Epub 2013 Jun 14.
PubMed 23771989Adawi M, Damiani G, Bragazzi NL, Bridgewood C, Pacifico A, Conic RRZ, Morrone A, Malagoli P, Pigatto PDM, Amital H, McGonagle D, Watad A. The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study. Nutrients. 2019 Mar 12;11(3):601. doi: 10.3390/nu11030601.
PubMed 30871045Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Van Voorhees AS, Gelfand JM. Psoriasis and comorbid diseases: Epidemiology. J Am Acad Dermatol. 2017 Mar;76(3):377-390. doi: 10.1016/j.jaad.2016.07.064.
PubMed 28212759Afifi L, Danesh MJ, Lee KM, Beroukhim K, Farahnik B, Ahn RS, Yan D, Singh RK, Nakamura M, Koo J, Liao W. Dietary Behaviors in Psoriasis: Patient-Reported Outcomes from a U.S. National Survey. Dermatol Ther (Heidelb). 2017 Jun;7(2):227-242. doi: 10.1007/s13555-017-0183-4. Epub 2017 May 19.
PubMed 28526915Pona A, Haidari W, Kolli SS, Feldman SR. Diet and psoriasis. Dermatol Online J. 2019 Feb 15;25(2):13030/qt1p37435s.
PubMed 30865402Fernandez-Armenteros JM, Gomez-Arbones X, Buti-Soler M, Betriu-Bars A, Sanmartin-Novell V, Ortega-Bravo M, Martinez-Alonso M, Gari E, Portero-Otin M, Santamaria-Babi L, Casanova-Seuma JM. Psoriasis, metabolic syndrome and cardiovascular risk factors. A population-based study. J Eur Acad Dermatol Venereol. 2019 Jan;33(1):128-135. doi: 10.1111/jdv.15159. Epub 2018 Jul 17.
PubMed 29953676Shelling ML, Kirsner RS. Practice gaps. Gaining insights into the relationship of obesity, weight loss, and psoriasis. JAMA Dermatol. 2013 Jul;149(7):801-2. doi: 10.1001/jamadermatol.2013.3383. No abstract available.
PubMed 23752561Debbaneh M, Millsop JW, Bhatia BK, Koo J, Liao W. Diet and psoriasis, part I: Impact of weight loss interventions. J Am Acad Dermatol. 2014 Jul;71(1):133-40. doi: 10.1016/j.jaad.2014.02.012. Epub 2014 Apr 4.
PubMed 24709272Zuccotti E, Oliveri M, Girometta C, Ratto D, Di Iorio C, Occhinegro A, Rossi P. Nutritional strategies for psoriasis: current scientific evidence in clinical trials. Eur Rev Med Pharmacol Sci. 2018 Dec;22(23):8537-8551. doi: 10.26355/eurrev_201812_16554.
PubMed 30556896Wu AG, Weinberg JM. The impact of diet on psoriasis. Cutis. 2019 Aug;104(2S):7-10.
PubMed 31634384de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.
PubMed 31881139Mattson MP, Longo VD, Harvie M. Impact of intermittent fasting on health and disease processes. Ageing Res Rev. 2017 Oct;39:46-58. doi: 10.1016/j.arr.2016.10.005. Epub 2016 Oct 31.
PubMed 27810402Anton SD, Moehl K, Donahoo WT, Marosi K, Lee SA, Mainous AG 3rd, Leeuwenburgh C, Mattson MP. Flipping the Metabolic Switch: Understanding and Applying the Health Benefits of Fasting. Obesity (Silver Spring). 2018 Feb;26(2):254-268. doi: 10.1002/oby.22065. Epub 2017 Oct 31.
PubMed 29086496
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intermittent Fasting on Disease Severity and Quality of Life in Psoriasis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05590247
- Acronym / sponsor ID
- 2022H0186
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- fasting, intermittent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This is 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.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting Group | Experimental | Behavioral: Intermittent Fasting DietPatients 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. |
| Standard Routine Diet Group | No intervention | –Patients will continue with their normal diets for the 24 week duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Fasting DietAlso: fasting, intermittent energy restrictionPatients 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. | Behavioural | Intermittent Fasting Group |
Primary outcome
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.
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%.
9 secondary outcomes
Patient Quality of life (Patient experience with their disease) by DLQI scoring
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Amount of skin involvement
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (overall)
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Enthesitis and Dactylitis Assessment
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Disease activity (nails)
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Weight
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Height
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Body Mass Index (BMI)
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Waist-to-hip ratio
Time frame: 0 weeks (baseline), 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 30691245Damiani G, Watad A, Bridgewood C, Pigatto PDM, Pacifico A, Malagoli P, Bragazzi NL, Adawi M. The Impact of Ramadan Fasting on the Reduction of PASI Score, in Moderate-To-Severe Psoriatic Patients: A Real-Life Multicenter Study. Nutrients. 2019 Jan 27;11(2):277. doi: 10.3390/nu11020277.
- Background: PubMed 29926091Ford AR, Siegel M, Bagel J, Cordoro KM, Garg A, Gottlieb A, Green LJ, Gudjonsson JE, Koo J, Lebwohl M, Liao W, Mandelin AM 2nd, Markenson JA, Mehta N, Merola JF, Prussick R, Ryan C, Schwartzman S, Siegel EL, Van Voorhees AS, Wu JJ, Armstrong AW. Dietary Recommendations for Adults With Psoriasis or Psoriatic Arthritis From the Medical Board of the National Psoriasis Foundation: A Systematic Review. JAMA Dermatol. 2018 Aug 1;154(8):934-950. doi: 10.1001/jamadermatol.2018.1412.
- Background: PubMed 23771989Di Minno MN, Peluso R, Iervolino S, Russolillo A, Lupoli R, Scarpa R; CaRRDs Study Group. Weight loss and achievement of minimal disease activity in patients with psoriatic arthritis starting treatment with tumour necrosis factor alpha blockers. Ann Rheum Dis. 2014 Jun;73(6):1157-62. doi: 10.1136/annrheumdis-2012-202812. Epub 2013 Jun 14.
- Background: PubMed 30871045Adawi M, Damiani G, Bragazzi NL, Bridgewood C, Pacifico A, Conic RRZ, Morrone A, Malagoli P, Pigatto PDM, Amital H, McGonagle D, Watad A. The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study. Nutrients. 2019 Mar 12;11(3):601. doi: 10.3390/nu11030601.
- Background: PubMed 28212759Takeshita J, Grewal S, Langan SM, Mehta NN, Ogdie A, Van Voorhees AS, Gelfand JM. Psoriasis and comorbid diseases: Epidemiology. J Am Acad Dermatol. 2017 Mar;76(3):377-390. doi: 10.1016/j.jaad.2016.07.064.
- Background: PubMed 28526915Afifi L, Danesh MJ, Lee KM, Beroukhim K, Farahnik B, Ahn RS, Yan D, Singh RK, Nakamura M, Koo J, Liao W. Dietary Behaviors in Psoriasis: Patient-Reported Outcomes from a U.S. National Survey. Dermatol Ther (Heidelb). 2017 Jun;7(2):227-242. doi: 10.1007/s13555-017-0183-4. Epub 2017 May 19.
- Background: PubMed 30865402Pona A, Haidari W, Kolli SS, Feldman SR. Diet and psoriasis. Dermatol Online J. 2019 Feb 15;25(2):13030/qt1p37435s.
- Background: PubMed 29953676Fernandez-Armenteros JM, Gomez-Arbones X, Buti-Soler M, Betriu-Bars A, Sanmartin-Novell V, Ortega-Bravo M, Martinez-Alonso M, Gari E, Portero-Otin M, Santamaria-Babi L, Casanova-Seuma JM. Psoriasis, metabolic syndrome and cardiovascular risk factors. A population-based study. J Eur Acad Dermatol Venereol. 2019 Jan;33(1):128-135. doi: 10.1111/jdv.15159. Epub 2018 Jul 17.
- Background: PubMed 23752561Shelling ML, Kirsner RS. Practice gaps. Gaining insights into the relationship of obesity, weight loss, and psoriasis. JAMA Dermatol. 2013 Jul;149(7):801-2. doi: 10.1001/jamadermatol.2013.3383. No abstract available.
- Background: PubMed 24709272Debbaneh M, Millsop JW, Bhatia BK, Koo J, Liao W. Diet and psoriasis, part I: Impact of weight loss interventions. J Am Acad Dermatol. 2014 Jul;71(1):133-40. doi: 10.1016/j.jaad.2014.02.012. Epub 2014 Apr 4.
- Background: PubMed 30556896Zuccotti E, Oliveri M, Girometta C, Ratto D, Di Iorio C, Occhinegro A, Rossi P. Nutritional strategies for psoriasis: current scientific evidence in clinical trials. Eur Rev Med Pharmacol Sci. 2018 Dec;22(23):8537-8551. doi: 10.26355/eurrev_201812_16554.
- Background: PubMed 31634384Wu AG, Weinberg JM. The impact of diet on psoriasis. Cutis. 2019 Aug;104(2S):7-10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin H Kaffenberger, MD, MS principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting Diet in people with Psoriasis and Psoriatic Arthritis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease activity (skin) by PASI scoring (time frame: 0 weeks (baseline), 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590247, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.