Intermittent Fasting Diet for Psoriasis and Psoriatic Arthritis

Overseen By Ashley N Gray, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Weight loss drugs

Disqualifiers: Pregnancy, Insulin-dependent diabetes, Severe heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

60 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 3 8 9}

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.

Research Team

Benjamin H. Kaffenberger, MD

Principal Investigator

Ohio State University

Eligibility 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

You weigh more than what is considered healthy for your height.

I have mild to moderate plaque psoriasis and treatments haven't worked.

Ability to consent and follow dietary instructions

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.

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

Treatment Details

Interventions

• Intermittent Fasting Diet

Trial Overview 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.

Participant Groups

Group I: Intermittent Fasting Group Experimental Treatment 1 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 Group Active Control 1 Intervention

Patients will continue with their normal diets for the 24 week duration of the study.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Psoriasis Foundation

Collaborator

Trials

12

Recruited

1,900+

Findings from Research

In a study of 108 patients with moderate-to-severe plaque psoriasis, fasting during Ramadan led to a significant reduction in the Psoriasis Area and Severity Index (PASI) score, indicating improved disease severity (mean difference = -0.89, p < 0.0001).

The effectiveness of psoriasis treatments varied, with cyclosporine and IL-17 blockers associated with lower PASI scores after fasting, while apremilast and phototherapy were linked to higher scores, suggesting that dietary and treatment strategies can influence psoriasis outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Ramadan Fasting on the Reduction of PASI Score, in Moderate-To-Severe Psoriatic Patients: A Real-Life Multicenter Study. Damiani, G., Watad, A., Bridgewood, C., et al.[2020]

A 2-week period of time-restricted feeding (TRF) significantly reduced psoriasis-like skin lesions in mice, indicating its potential as a therapeutic approach for managing psoriasis.

TRF was found to lower inflammatory cytokines and decrease the number of senescent T cells, while increasing regulatory T cells (CD4+ Treg) in skin lesions, suggesting a mechanism of action that involves modulating immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 2-week time-restricted feeding attenuates psoriasis-like lesions with reduced inflammatory cytokines and immunosenescence in mice. Chen, Y., Li, X., Yang, M., et al.[2023]

Japanese psoriatic patients have distinct dietary habits compared to Western patients, showing higher body mass indices and a greater intake of fish, pulses, and certain vitamins, while consuming less meat.

The study found that psoriasis is associated with a high body mass index and low meat intake, and patients with higher disease severity (as measured by the Psoriasis Area and Severity Index) consumed more confectionery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yamashita, H., Morita, T., Ito, M., et al.[2022]

An energy-restricted diet rich in n-3 polyunsaturated fatty acids (PUFAs) significantly improved clinical outcomes in 44 obese patients with psoriasis over six months, including reductions in psoriasis severity, itch scores, and quality of life measures.

This diet also led to notable improvements in metabolic markers, such as decreased body weight, waist circumference, and serum triglycerides, suggesting that dietary changes can enhance the effectiveness of immuno-modulating therapies in treating psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Guida, B., Napoleone, A., Trio, R., et al.[2015]

A pilot study involving 24 psoriasis patients will investigate the effects of modified intermittent fasting (MIF) on skin, gut, and metabolic health, comparing it to a regular diet over 12-week periods.

The study aims to assess various health markers, including psoriasis severity and inflammation, to determine how dietary lifestyle changes like MIF can improve psoriasis management and overall health without relying solely on medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. Grine, L., Hilhorst, N., Michels, N., et al.[2022]

In a study of 56 patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA), Ramadan fasting led to a significant decrease in disease activity for RA, with Disease Activity Scores improving from 4.3 to 3.5 (p < 0.001).

Fasting did not negatively impact medication compliance or tolerance, suggesting that patients can safely fast without fear of compromising their treatment regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Ramadan diurnal intermittent fasting on rheumatic diseases. Ben Nessib, D., Maatallah, K., Ferjani, H., et al.[2021]

In a study of 37 patients with psoriatic arthritis who fasted for 17 hours daily during Ramadan, significant improvements were observed in disease activity markers, including a decrease in C-reactive protein levels and various disease activity indices, indicating that intermittent fasting may help reduce inflammation and symptoms associated with psoriatic arthritis.

The study suggests that fasting can be a predictor of decreased disease activity in psoriatic arthritis, independent of weight loss, highlighting the potential role of circadian fasting as a therapeutic approach in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study. Adawi, M., Damiani, G., Bragazzi, NL., et al.[2020]

In a study of 13,284 participants, the dietary inflammatory index (DII) was not found to be associated with the occurrence of psoriasis, suggesting that diet-induced inflammation may not play a significant role in developing this skin condition.

Despite the potential health risks of a pro-inflammatory diet, the analysis indicated that individuals with higher DII scores did not have a higher risk of psoriasis compared to those with lower scores, highlighting the complexity of dietary impacts on skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary inflammatory potential and psoriasis: A cross-sectional study. Liu, N., Zhang, C., Hua, W.[2023]

The Diet and Psoriasis Project (DIEPP) is investigating the relationship between dietary factors and psoriasis severity, focusing on the Mediterranean diet and time-restricted eating as potential therapeutic strategies.

This research aims to provide insights into how diet may influence psoriasis and contribute to developing medically approved dietary recommendations, addressing the link between psoriasis and associated conditions like type 2 diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). Zanesco, S., Hall, W., Gibson, R., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Ramadan Fasting on the Reduction of PASI Score, in Moderate-To-Severe Psoriatic Patients: A Real-Life Multicenter Study. [2020]

2. Denmark pubmed.ncbi.nlm.nih.gov

A 2-week time-restricted feeding attenuates psoriasis-like lesions with reduced inflammatory cytokines and immunosenescence in mice. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. Canada pubmed.ncbi.nlm.nih.gov

The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Impact of Ramadan diurnal intermittent fasting on rheumatic diseases. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Dietary inflammatory potential and psoriasis: A cross-sectional study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). [2023]