Role of Intermittent Fasting in Psoriasis and Psoriatic Arthritis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590247
• Other study ID #: 2022H0186
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Ashley N Gray, BS
• Phone: 6142931707
• Email: ashley.gray[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Psoriasis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: N Engl J Med. 2020 Jan 16;382(3):298. N Engl J Med. 2020 Mar 5;382(10):978. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Dermatol. 2013 Aug;149(8):997. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Wu AG, Weinberg JM. The impact of diet on psoriasis. Cutis. 2019 Aug;104(2S):7-10. Erratum In: Cutis. 2019 Oct;104(4):241. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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%.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	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.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Amount of skin involvement	Body surface area (0-100%)	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Disease activity (overall)	Physician's Global Assessment (score 0-4, 4 being worst)	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Enthesitis and Dactylitis Assessment	Will be scored on presence/absence of dactylitis and enthesitis based on physical exam.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	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	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Weight	Weight will be obtained in kilograms using traditional clinical scale.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Height	Height will be obtained in meters using traditional clinical scale.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Body Mass Index (BMI)	BMI assessed by obtaining weight (kg) and height (m) from traditional clinical scale and calculating.	0 weeks (baseline), 12 weeks, 24 weeks
Secondary	Waist-to-hip ratio	Waist-to-hip ratio will be measured using tape measure in centimeters and reported as a ratio.	0 weeks (baseline), 12 weeks, 24 weeks