Role of Intermittent Fasting in Psoriasis and Psoriatic Arthritis

NCT05590247 | Active Not Recruiting

• 1 other identifier: 2022H0186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

fasting; intermittent

Outcome Measures

Primary Outcomes (2)

• 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.

  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: 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 Outcomes (9)

• Patient Quality of life (Patient experience with their disease) by DLQI scoring

  0 weeks (baseline), 12 weeks, 24 weeks

• Amount of skin involvement

  0 weeks (baseline), 12 weeks, 24 weeks

• Disease activity (overall)

  0 weeks (baseline), 12 weeks, 24 weeks

• Enthesitis and Dactylitis Assessment

  0 weeks (baseline), 12 weeks, 24 weeks

• Disease activity (nails)

  0 weeks (baseline), 12 weeks, 24 weeks

Study Arms (2)

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.

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.

Interventions

Intermittent Fasting Diet BEHAVIORAL

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.

Also known as: fasting, intermittent energy restriction

Intermittent Fasting Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• National Psoriasis Foundation: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43201, United States

Location

Related Publications (23)

• 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.

  PMID: 30691245 BACKGROUND

• Ford 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.

  PMID: 29926091 BACKGROUND

• Di 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.

  PMID: 23771989 BACKGROUND

• Adawi 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.

  PMID: 30871045 BACKGROUND

• Takeshita 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.

  PMID: 28212759 BACKGROUND

• Afifi 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.

  PMID: 28526915 BACKGROUND

• Pona A, Haidari W, Kolli SS, Feldman SR. Diet and psoriasis. Dermatol Online J. 2019 Feb 15;25(2):13030/qt1p37435s.

  PMID: 30865402 BACKGROUND

• Fernandez-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.

  PMID: 29953676 BACKGROUND

• Shelling 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.

  PMID: 23752561 BACKGROUND

• Debbaneh 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.

  PMID: 24709272 BACKGROUND

• Zuccotti 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.

  PMID: 30556896 BACKGROUND

• Wu AG, Weinberg JM. The impact of diet on psoriasis. Cutis. 2019 Aug;104(2S):7-10.

  PMID: 31634384 BACKGROUND

• de 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.

  PMID: 31881139 BACKGROUND

• Mattson 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.

  PMID: 27810402 BACKGROUND

• Anton 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.

  PMID: 29086496 BACKGROUND

• Yang F, Liu C, Liu X, Pan X, Li X, Tian L, Sun J, Yang S, Zhao R, An N, Yang X, Gao Y, Xing Y. Effect of Epidemic Intermittent Fasting on Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Nutr. 2021 Oct 18;8:669325. doi: 10.3389/fnut.2021.669325. eCollection 2021.

  PMID: 34733872 BACKGROUND

• Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Effect of weight loss on the severity of psoriasis: a randomized clinical study. JAMA Dermatol. 2013 Jul;149(7):795-801. doi: 10.1001/jamadermatol.2013.722.

  PMID: 23752669 BACKGROUND

• Bragazzi NL, Sellami M, Salem I, Conic R, Kimak M, Pigatto PDM, Damiani G. Fasting and Its Impact on Skin Anatomy, Physiology, and Physiopathology: A Comprehensive Review of the Literature. Nutrients. 2019 Jan 23;11(2):249. doi: 10.3390/nu11020249.

  PMID: 30678053 BACKGROUND

• Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.

  PMID: 31614992 BACKGROUND

• Plikus MV, Van Spyk EN, Pham K, Geyfman M, Kumar V, Takahashi JS, Andersen B. The circadian clock in skin: implications for adult stem cells, tissue regeneration, cancer, aging, and immunity. J Biol Rhythms. 2015 Jun;30(3):163-82. doi: 10.1177/0748730414563537. Epub 2015 Jan 13.

  PMID: 25589491 BACKGROUND

• Adawi M, Watad A, Brown S, Aazza K, Aazza H, Zouhir M, Sharif K, Ghanayem K, Farah R, Mahagna H, Fiordoro S, Sukkar SG, Bragazzi NL, Mahroum N. Ramadan Fasting Exerts Immunomodulatory Effects: Insights from a Systematic Review. Front Immunol. 2017 Nov 27;8:1144. doi: 10.3389/fimmu.2017.01144. eCollection 2017.

  PMID: 29230208 BACKGROUND

• Macklis P, Adams KM, Li D, Krispinsky A, Bechtel M, Trinidad J, Kaffenberger J, Kumar P, Kaffenberger BH. The impacts of oral health symptoms, hygiene, and diet on the development and severity of psoriasis. Dermatol Online J. 2019 Jul 15;25(7):13030/qt85z4t7hq.

  PMID: 31450285 BACKGROUND

• Macklis PC, Tyler K, Kaffenberger J, Kwatra S, Kaffenberger BH. Lifestyle modifications associated with symptom improvement in hidradenitis suppurativa patients. Arch Dermatol Res. 2022 Apr;314(3):293-300. doi: 10.1007/s00403-021-02233-y. Epub 2021 Apr 23.

  PMID: 33893517 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Feeding Behavior; Behavior

Study Officials

• Benjamin H Kaffenberger, MD, MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Care provider and investigator are blinded to the arm, but patient has to know which diet to follow and outcomes assessor assigned the groups and has to counsel patients accordingly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 21, 2022
• Study Start: July 21, 2022
• Primary Completion: March 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)