Clinical trial NCT06905028: Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)
Official title: The Impact of Fasting on Disease Activity and the Gut Microbiota in Patients with Psoriasis and Psoriatic Arthritis - the RiseFast Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis Arthritis
Psoriasis (PsO)
Keywords: fasting
vegan
plant-based
diet
psoriasis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Max Delbrück Center for Molecular Medicine (MDC), Berlin
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The RiseFast pilot study will investigate the clinical, metabolic and immunological effects of fasting and plant-based diet (PBD) on patients with psoriasis (PsO) and psoriatic arthritis (PsA) on their gut microbiota. The project will combine clinical assessments, cytometric profiling, and gut microbiota analysis to explore the relationship between fasting, a plant-based diet, and psoriatic disease. The study includes a 7-day fasting period followed by 11 weeks of PBD, with the goal of improving disease activity, quality of life, and understanding the role of gut microbiota in these conditions. This approach could lead to low-cost, accessible therapeutic options with minimal side effects.

Detailed description: Psoriatic disease, encompassing psoriasis (PsO) and psoriatic arthritis (PsA) is a chronic inflammatory condition influenced by genetic, immune, and environmental factors, particularly diet and gut microbiota. While biologics and DMARDs have improved disease management, treatment responses vary, and long-term remission remains difficult. Continuous inflammation control often requires pharmacological treatment, highlighting the need for adjunctive therapies.

Emerging research links gut microbiota imbalances (dysbiosis) to chronic inflammation, suggesting that dietary interventions could offer therapeutic benefits. Fasting and plant-based diets (PBD) may help regulate immune responses and gut microbiota composition. Fasting has been shown to reduce oxidative stress, promote autophagy, and alter immune cell dynamics, while PBD is associated with anti-inflammatory effects and enhanced microbial diversity.

The RiseFast Pilot Study aims to investigate whether a seven-day fasting period followed by a structured PBD can improve disease activity, quality of life, and gut microbiota in PsO and PsA patients. While prior studies suggest potential benefits, their specific effects on psoriatic disease remain unclear. By integrating clinical, microbiome, and immune profiling, the study aims to clarify dietary impacts on inflammation.

Eligibility criteria: Inclusion Criteria:

* Active plaque psoriasis (PASI ≥3) or Psoriatic Arthritis fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) and not meeting MDA criteria
* on stable baseline psoriatic treatment for 12 weeks before enrollment
* ≥ 18 years old

Exclusion Criteria:

* Pregnancy or breastfeeding
* underweight (BMI ≤18,5)
* eating disorder in the last 5 years
* severe internal diseases (e.g. renal insufficiency with creatinine \> 2mg/dl)
* current practice of vegan diet or fasting within the past 6 months
* use of antibiotics within the past 3 months

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Disease Activity index for PSoriatic Arthritis (DAPSA)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Secondary outcomes:
measure: Sociodemographic Measurements
timeFrame: Date of inclusion (baseline)
measure: Medication intake
timeFrame: Date of inclusion (baseline), after 6 and 12 weeks
measure: Quantification of Behavioral Factors
timeFrame: Date of inclusion (baseline), after 6 and 12 weeks
measure: Behavioral Factors: alcohol consumption
timeFrame: Date of inclusion (baseline), after 6 and 12 weeks
measure: Behavioral Factors: smoking
timeFrame: Date of inclusion (baseline), after 6 and 12 weeks
measure: Expectation questions
timeFrame: Date of inclusion (baseline)
measure: Resting blood pressure (mmHg)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Pulse rate (bmp)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Abdominal circumference (cm)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Waist to Hip Ratio (cm)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Weight (kg)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Body Mass Index (kg/m2)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Bio-electrical impedance analysis (BIA)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Body Surface Area (BSA)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Nail Psoriasis Severity Index (NAPSI)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Criteria of minimal disease activity (MDA) or very low disease activity (VLDA)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: 68 Tender Joint Count
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: 66 Swollen Joint Count
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Leeds Enthesitis Index (LEI)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: ACR20/50 criteria
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Quality of Life questionnaire (WHO-5)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: EULAR Psoriatic Arthritis Impact of Disease (PsAID12)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Subjective strength of the main complaint (Visual Analogue Scale)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Short Form 36
timeFrame: Date of inclusion (baseline) and after 12 weeks
measure: Food selection
timeFrame: Date of inclusion (baseline), after 4 and 9 weeks
measure: Dietary Behaviour
timeFrame: Date of inclusion (baseline), after 6 and 12 weeks
measure: Differential blood count
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: CRP in milligram per liter (mg/L)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Creatinine in µmol per liter (µmol/L)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Ketone bodies (mmol/l)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Glucose (mg/dl)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Hepatic transaminases (ALAT, ASAT)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Electrolytes
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Flow cytometry: Phenotyping of immune cells
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Cytokine profile
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Functional immune cell tests
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: NK cell activity
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Autoantibodies
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Gene expression analysis
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Epigenetic analysis
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Metabolomics
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Biobanking (for future proteomics analysis)
timeFrame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
measure: Gut microbiota characterization
timeFrame: Date of inclusion (baseline), day 8 or first stool after fasting, after 6 and 12 weeks
Other outcomes:
measure: Final questionnaire to record tolerability of fasting and nutrition, adverse effects
timeFrame: After 12 weeks
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum
Study officials:
References: