Intermittent Fasting Diet for Psoriasis and Psoriatic Arthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Must not be taking: Weight loss drugs
Disqualifiers: Pregnancy, Insulin-dependent diabetes, Severe heart disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have changed your systemic psoriasis treatment in the 6 weeks before joining the study.
What data supports the effectiveness of the intermittent fasting diet treatment for psoriasis and psoriatic arthritis?
Research shows that fasting during Ramadan, which involves intermittent fasting, significantly reduced psoriasis severity in patients. Additionally, a study on mice found that time-restricted feeding, a form of intermittent fasting, reduced psoriasis-like skin lesions and inflammation.
12345Is intermittent fasting safe for humans?
Intermittent fasting, such as during Ramadan, has been practiced worldwide and is generally considered safe for most people. Studies have shown it can reduce inflammation and improve certain health conditions, but it's important to consult with a healthcare provider before starting, especially if you have existing health issues.
12367How does intermittent fasting differ from other treatments for psoriasis and psoriatic arthritis?
Intermittent fasting, such as time-restricted eating, is unique because it focuses on when you eat rather than what you eat, potentially reducing inflammation and improving immune function, which may help manage psoriasis and psoriatic arthritis. Unlike traditional treatments that often involve medications, this approach leverages dietary timing to influence the body's biological clock and circadian rhythm, offering a novel way to address these conditions.
12389Eligibility Criteria
This trial is for adults over 18 with mild to moderate plaque psoriasis, who are overweight and have been stable on their current psoriasis treatment for at least 6 weeks. It's not suitable for insulin-dependent diabetics, pregnant or breastfeeding individuals, those with severe organ disease, or anyone using medical weight loss treatments.Inclusion Criteria
I am 18 years old or older.
You weigh more than what is considered healthy for your height.
I have mild to moderate plaque psoriasis and treatments haven't worked.
+2 more
Exclusion Criteria
My obesity is caused by a medical condition.
I do not have severe heart, kidney, or liver disease.
I use insulin for my diabetes.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are enrolled in a dietary intervention for a 24-week period, with an initial 12 weeks of intermittent fasting or standard routine diet, followed by 12 weeks of normal dietary habits.
24 weeks
6 visits (virtual) every 4 weeks
Follow-up
Participants are monitored for changes in disease state and quality of life after returning to their initial dietary routines.
12 weeks
1 visit (virtual) at the end of the study
Participant Groups
The study tests if an Intermittent Fasting Diet (IMF) can improve the severity of psoriasis and Psoriatic Arthritis (PsA), as well as quality of life. Participants will either follow the IMF diet or their usual diet for 24 weeks. The effects will be monitored through regular check-ins and assessments by a physician.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intermittent Fasting GroupExperimental Treatment1 Intervention
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.
Group II: Standard Routine Diet GroupActive Control1 Intervention
Patients will continue with their normal diets for the 24 week duration of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State University Wexner Medical CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
National Psoriasis FoundationCollaborator
References
The Impact of Ramadan Fasting on the Reduction of PASI Score, in Moderate-To-Severe Psoriatic Patients: A Real-Life Multicenter Study. [2020]Fasting during the month of Ramadan consists of alternate abstinence and re-feeding periods (circadian or intermittent fasting). Nothing is currently known on the impact of this kind of fasting on psoriasis. A sample of 108 moderate-to-severe plaque psoriasis patients (aged 42.84 ± 13.61 years, 62 males, 46 females) volunteered to take part in the study. A significant decrease in the "Psoriasis Area and Severity Index" (PASI) score after the Ramadan fasting (mean difference = -0.89 ± 1.21, p < 0.0001) was found. At the multivariate regression, the use of cyclosporine (p = 0.0003), interleukin-17 or IL-17 blockers (p < 0.0001), and tumor necrosis factor or TNF blockers (p = 0.0107) was independently associated with a low PASI score, while the use of apremilast (p = 0.0009), and phototherapy (p = 0.0015) was associated with a high PASI score before the Ramadan fasting. Similarly, the consumption of cyclosporine (p < 0.0001), IL-17 blockers (p < 0.0001), mammalian target of rapamycin or mTOR inhibitors (p = 0.0081), and TNF blockers (p = 0.0017) predicted a low PASI score after the Ramadan fasting. By contrast, narrow band ultraviolet light B or NB-UVB (p = 0.0015) was associated with a high PASI score after Ramadan fasting. Disease duration (p = 0.0078), use of apremilast (p = 0.0005), and of mTOR inhibitors (p = 0.0034) were independent predictors of the reduction in the PASI score after the Ramadan fasting. These findings reflect the influence of dieting strategy, the biological clock, and circadian rhythm on the treatment of plaque psoriasis.
A 2-week time-restricted feeding attenuates psoriasis-like lesions with reduced inflammatory cytokines and immunosenescence in mice. [2023]Psoriasis, a well-established T-cell mediated dermatosis, exhibits a robust correlation with obesity and systemic inflammation, manifesting psoriasis skin lesions and premature immunosenescence within the peripheral blood and lesion. Intermittent fasting (IF) has exhibited various beneficial effects in reducing inflammation, resisting oxidative stress and slowing ageing, as well as losing weight. A form of IF known as time-restricted feeding (TRF) restricts daily caloric intake within 4-8 h. Nonetheless, the advantageous impacts of TRF on psoriasis still require further verification. We measured the acanthosis in Imiquimod (IMQ)-induced psoriasis mice and evaluated their pathological phenotypes. Our study examined the effects of a 2-week TRF on body weight and metabolic parameters. The subsets of T cells in spleens and skin lesions were accessed by flow cytometry. Cytokines and senescence-associated genes were evaluated by immunofluorescence and RT-qPCR. RNA sequencing was conducted on skin lesions. According to our findings, a 2-week TRF attenuates psoriasis-like lesions in mice with reduced inflammatory cytokines and mitigated immunosenescence. TRF increased the counts of CD4+ Treg cells in skin lesions while reducing the counts of Th2 and Th17 cells in spleens. Furthermore, the administration of TRF resulted in a decrease in the population of CD4+ senescent T cells in both the dermis and spleens, concomitant with the expression of senescence-associated genes in spleen CD4+ T cells. The outcomes mentioned above provide valuable evidence in support of TRF for the management of psoriasis.
Dietary habits in Japanese patients with psoriasis and psoriatic arthritis: Low intake of meat in psoriasis and high intake of vitamin A in psoriatic arthritis. [2022]Psoriasis is characterized by T-helper 17 cell-dominant abnormal immunity, and hyperproliferation and abnormal differentiation of epidermal keratinocytes. Some patients are associated with arthritis. Dietary habits can modulate the pathogenesis of psoriasis. Previous studies in Western countries showed higher body mass indices, higher intake of fat and lower intake of fish or vegetables in psoriatic patients compared with the reference groups. We evaluated dietary habits in adult Japanese psoriatic patients, using a validated brief-type self-administered dietary history questionnaire, and compared the results to those of age- and sex-matched healthy controls. The results in psoriatic patients with arthritis were compared with those in the patients without. Japanese psoriatic patients showed higher body mass indices, higher intake of fish/shellfish, pulses, sugar/sweeteners, vitamin B12 and vitamin D, and lower intake of meat, compared with those of healthy controls. The logistic regression analysis showed that psoriasis was associated with high body mass index and low intake of meat. The intake of confection in patients with high Psoriasis Area and Severity Index was higher than that in those with low index. The intake of β-carotene, vitamin A and green/yellow vegetables in psoriatic patients with arthritis were higher than those in the patients without. The dietary habits in Japanese psoriatic patients are rather different from those in Western patients. This is the first study showing the differences in dietary habits between psoriatic patients with arthritis and those without. Further studies should elucidate the relationships of these results with skin and joint lesions in psoriatic patients.
Energy-restricted, n-3 polyunsaturated fatty acids-rich diet improves the clinical response to immuno-modulating drugs in obese patients with plaque-type psoriasis: a randomized control clinical trial. [2015]Low-grade systemic inflammation associated with obesity may worsen the clinical course of psoriasis. This study aimed to assess the effectiveness of an energy-restricted diet, enriched in n-3 polyunsaturated fatty acids (PUFAs) and poor in n-6 PUFAs, on metabolic markers and clinical outcome of obese patients with psoriasis.
The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. [2022]Psoriasis is a complex disease associated with multiple comorbidities, including metabolic syndrome and leaky gut syndrome. Dietary lifestyle interventions have been reported to affect the disease in terms of lesional severity. It remains unclear how diets affect these comorbidities and the general health in psoriasis patients. Modified intermittent fasting (MIF) on 2 nonconsecutive days has shown beneficial effects on metabolic parameters. A significant advantage of MIF over the currently investigated dietary changes is its feasibility.
Impact of Ramadan diurnal intermittent fasting on rheumatic diseases. [2021]Ramadan intermittent fasting is observed by Muslims from sunrise to sunset and alternated with moments of re-feeding. The aims of this study were to assess the impact of Ramadan fasting on rheumatoid arthritis (RA) and spondyloarthritis (SpA) activity and to assess its impact on chronic medications intake in patients with rheumatic diseases.
The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study. [2020]Intermittent circadian fasting, namely Ramadan, is a common worldwide practice. Such fasting has a positive impact on psoriasis, but no data exist on its role in psoriatic arthritis (PsA)-a disease that is clearly linked to body mass index. We enrolled 37 patients (23 females and 14 males) with a mean age 43.32 ± 7.81 and they fasted for 17 h for one month in 2016. The baseline PsA characteristics were collected and 12 (32.4%) patients had peripheral arthritis, 13 (35.1%) had axial involvement, 24 (64.9%) had enthesitis, and 13 (35.1%) had dactylitis. Three patients (8.1%) were treated with methotrexate, 28 (75.7%) with TNF-α blockers, and 6 (16.2%) with IL-17 blockers. After a month of intermittent fasting, C-reactive protein (CRP) levels decreased from 14.08 ± 4.65 to 12.16 ± 4.46 (p < 0.0001), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) decreased from 2.83 ± 1.03 to 2.08 ± 0.67 (p = 0.0078), Psoriasis Area Severity Index (PASI) decreased from 7.46 ± 2.43 to 5.86 ± 2.37 (p < 0.0001), and Disease Activity index for PSoriatic Arthritis (DAPSA) decreased from 28.11 ± 4.51 to 25.76 ± 4.48 (p < 0.0001). Similarly, enthesitis improved after fasting, with Leeds Enthesitis Index (LEI) decreasing from 2.25 ± 1.11 to 1.71 ± 0.86 (p < 0.0001) and dactylitis severity score (DSS) decreasing from 9.92 ± 2.93 to 8.54 ± 2.79 (p = 0.0001). Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting. These preliminary data may support the use of chronomedicine in the context of rheumatic diseases, namely PsA. Further studies are needed to support our findings.
Dietary inflammatory potential and psoriasis: A cross-sectional study. [2023]Diet is an important source of inflammation, and diet-induced inflammation might be associated with the etiopathogenesis of psoriasis. This study aimed to explore the relationship between dietary inflammatory index (DII), a literature-derived dietary tool to measure individual dietary inflammatory potential, and incident psoriasis. This was a cross-sectional study based on the 2003-2006 and 2009-2014 National Health and Nutrition Examination Surveys. The calculation of DII was based on 24-h dietary recall. Psoriasis was defined by a self-reported medical questionnaire. Logistic regressions were introduced to calculate the odds ratio (OR) and 95% confidence interval (CI) of psoriasis relative to DII. Restricted cubic splines (RCS) were used to test the nonlinear relationship in the regression model. A total of 13 284 participants with an average age of 48.94 ± 17.71 years were enrolled. The prevalence rate psoriasis was 2.88% (95% CI 2.61, 3.18). Incident psoriasis was not associated with DII in a multivariable logistic regression model (OR = 1.00, 95% CI 0.89, 1.11). Compared to participants in the lowest DII tertile, OR for those in the highest was 0.81 (95% CI 0.51, 1.28, P for trend = 0.0974). Subgroup analysis indicated that DII was still not associated with psoriasis in participants with different population settings. RCS showed that DII was not associated with psoriasis in either an overall or a nonlinear manner. Although a proinflammatory diet could lead to several health risks, psoriasis occurrence might not be associated with dietary inflammatory potential in this cross-sectional study.
Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). [2023]Psoriasis is an immune-mediated inflammatory skin disease affecting approximately 2% of the UK population. Its pathogenesis is suggested to be an outcome of genetic and environmental interplay. People with psoriasis have an increased likelihood of developing other conditions such as type 2 diabetes and cardiovascular disease. Systemic inflammation is hypothesised to be the common link between psoriasis and cardio-metabolic diseases. Emerging evidence shows diet as a potential therapeutic adjunct in the management of psoriasis. The Diet and Psoriasis Project (DIEPP) aims to investigate whether dietary factors are related to psoriasis severity by conducting an observational study followed by a dietary intervention trial, to assess the effect of the Mediterranean diet (MedD) and time-restricted eating (TRE) on psoriasis. This review article will explore the potential mechanisms by which the MedD and TRE may exert protective effects on psoriasis, evaluate the current evidence, and outline the design of the DIEPP. Given the early-stage evidence, we hope to be able to build knowledge to derive medically approved dietary recommendations and contribute to the research gaps exploring the role of diet and psoriasis.