Clinical trial NCT05590247: Role of Intermittent Fasting in Psoriasis and Psoriatic Arthritis
Official title: Role of Intermittent Fasting on Disease Severity and Quality of Life in Psoriasis and Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Psoriatic Arthritis
Keywords: fasting
intermittent
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2022-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Disease activity (skin) by PASI scoring
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Change in Disease activity (joints) by PsARC scoring
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
Secondary outcomes:
measure: Patient Quality of life (Patient experience with their disease) by DLQI scoring
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Amount of skin involvement
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Disease activity (overall)
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Enthesitis and Dactylitis Assessment
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Disease activity (nails)
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Weight
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Height
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Body Mass Index (BMI)
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
measure: Waist-to-hip ratio
timeFrame: 0 weeks (baseline), 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Benjamin H Kaffenberger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
citation: Pona A, Haidari W, Kolli SS, Feldman SR. Diet and psoriasis. Dermatol Online J. 2019 Feb 15;25(2):13030/qt1p37435s.
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.
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.
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.
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.
citation: Wu AG, Weinberg JM. The impact of diet on psoriasis. Cutis. 2019 Aug;104(2S):7-10.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.