Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)

Not Applicable

Recruiting

• Conditions: Psoriasis Arthritis; Psoriasis (PsO)

• Registration Number: NCT06905028
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Start: 2025-04-30
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Changes in disease activity measured by the Psoriasis Area and Severity Index (PASI) after 12 weeks compared to baseline.
Disease Activity index for PSoriatic Arthritis (DAPSA)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Changes in disease activity measured by the Disease Activity index for Psoriatic Arthritis (DAPSA) after 12 weeks compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic Measurements	Date of inclusion (baseline)	age, education level, household income, employment status, marital status, complete family history of Psoriasis and/or Psoriatic Arthritis in first- and second-degree relatives, current and previous illness and co-morbidities, and current medications.
Medication intake	Date of inclusion (baseline), after 6 and 12 weeks	Systematized documentation of medication, main and secondary diagnoses using CRF.
Quantification of Behavioral Factors	Date of inclusion (baseline), after 6 and 12 weeks	Sleeping habits, Physical Activity, Stress and Media Consumption via Likert Scales, range from 0 to 10 while higher values meaning a higher grade of agreement.
Behavioral Factors: alcohol consumption	Date of inclusion (baseline), after 6 and 12 weeks	Number of alcoholic beverages on average per week in the last month.
Behavioral Factors: smoking	Date of inclusion (baseline), after 6 and 12 weeks	Smoking status in packyears.
Expectation questions	Date of inclusion (baseline)	For fasting on a 10-point likert scale from 1 (nothing at all) to 10 (very strong).
Resting blood pressure (mmHg)	Date of inclusion (baseline), day 8, after 6 and 12 weeks
Pulse rate (bmp)	Date of inclusion (baseline), day 8, after 6 and 12 weeks
Abdominal circumference (cm)	Date of inclusion (baseline), day 8, after 6 and 12 weeks
Waist to Hip Ratio (cm)	Date of inclusion (baseline), day 8, after 6 and 12 weeks
Weight (kg)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change in weight (kg)
Body Mass Index (kg/m2)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change in Body Mass Index measured as weight (kg) and height (m) (kg/m\^2)
Bio-electrical impedance analysis (BIA)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Body Surface Area (BSA)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Body Surface Area (BSA) quantifies the percentage of skin affected by psoriasis, with one palm equating to approximately 1% of the total body surface. Values range from 0% to 100%, with higher percentages indicating greater skin involvement.
Nail Psoriasis Severity Index (NAPSI)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Nail Psoriasis Severity Index (NAPSI) evaluates the severity of nail psoriasis. It assesses each fingernail for specific features in the nail matrix (pitting, leukonychia, crumbling, red spots in the lunula) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop discoloration). Each nail is scored from 0 to 8, with higher scores indicating more severe nail involvement.
Criteria of minimal disease activity (MDA) or very low disease activity (VLDA)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Minimal Disease Activity (MDA) is a composite assessment of disease activity state in PsA. It includes 7 components: tender joint count (68) ≤ 1, swollen joint count (66) ≤ 1, Psoriasis Area Severity Index ≤ 1/Body Surface Area ≤ 3, enthesitis≤ 1, patient global assessment of disease activity VAS ≤ 20, pain VAS ≤ 15 and HAQ-DI ≤ 0.5. MDA requires 5 out of 7 components to be met; Very Low Disease Activity (VLDA) is a stricter composite assessment of disease activity state in Psoriatic Arthritis (PsA). It includes 7 components, all of which must be fulfilled to achieve VLDA: tender joint count (68): ≤ 1; Swollen joint count (66): ≤ 1; Psoriasis Area and Severity Index (PASI): ≤ 1 or Body Surface Area (BSA): ≤ 1%; Enthesitis count: 0 (no active enthesitis); Patient global assessment of disease activity (VAS): ≤ 20; Pain assessment (VAS): ≤ 15; Health Assessment Questionnaire Disability Index (HAQ-DI): ≤ 0.5
68 Tender Joint Count	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change in Tender Joint Count at Week 12 as compared to baseline, with a maximum possible range between 0 to 68 with higher values indicating a worsening of the symptoms.
66 Swollen Joint Count	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change in Swollen Joint Count at Week 12 as compared to baseline, with a maximum possible range between 0 to 66 with higher values indicating a worsening of the symptoms.
Leeds Enthesitis Index (LEI)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Leeds Enthesitis Index (LEI) is used to assess enthesitis in psoriatic arthritis (PsA). It evaluates tenderness (1 = present, 0 = absent) at six specific sites: the lateral epicondyles (elbows), medial femoral condyles (knees), and Achilles tendon insertions (heels) on both sides of the body. The total score ranges from 0 (no tenderness) to 6 (tenderness at all sites).
ACR20/50 criteria	Date of inclusion (baseline), day 8, after 6 and 12 weeks	ACR20/50 and ACR50 response criteria assess treatment efficacy in psoriatic arthritis. Achievement of ACR20 requires a ≥20% improvement in both the tender joint count (68 joints) and the swollen joint count (66 joints), in addition to a ≥20% improvement in at least three of the following five domains: patient global assessment of disease activity (VAS 0-100), physician global assessment of disease activity (VAS 0-100), pain assessment (VAS 0-100), physical function (e.g., HAQ-DI), and acute-phase reactants (CRP or ESR). Similarly, ACR50 requires a ≥50% improvement in these parameters, reflecting a more substantial reduction in disease activity.
Health Assessment Questionnaire Disability Index (HAQ-DI)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change from Baseline in the HAQ after 12 weeks, range from 0 to 3 while higher values meaning a higher grade of disability.
Quality of Life questionnaire (WHO-5)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Change from Baseline in the WHO-5, range from 0 to 100 %, higher values meaning a higher grade of well-being.
Dermatology Life Quality Index (DLQI)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Changes from Baseline in the DLQI after 12 weeks, range from 0 to 3, higher values meaning a lower grade of life quality.
EULAR Psoriatic Arthritis Impact of Disease (PsAID12)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Changes from Baseline in the PsAID-12, formed of 12 questions, each evaluated on a 0-10 numeric rating scale, where a higher score reflects a greater impact of PsA.
Subjective strength of the main complaint (Visual Analogue Scale)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	The Visual Analog Scale for Pain (VAS Pain) and the Visual Analog Scale for Skin Complaints (VAS Skin Complaints) both range from 0 to 10, with higher values indicating more severe symptoms.
Short Form 36	Date of inclusion (baseline) and after 12 weeks	36-Item Short Form Survey (SF-36) used as Quality of life assessment, containing 36 items, the total score range from 0 to 100, a high score represents a high quality of life).
Food selection	Date of inclusion (baseline), after 4 and 9 weeks	Nutritional history via dietary record (3-day food record)
Dietary Behaviour	Date of inclusion (baseline), after 6 and 12 weeks	The Food Frequency Questionnaire (FFQ) records dietary behaviors such as mealtimes, frequency of food intake, food preferences, and fasting experiences.
Differential blood count	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Analysis of different types of blood cells to assess immune status and detect possible infections or inflammations.
CRP in milligram per liter (mg/L)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	CRP (C-reactive protein) as a marker of inflammatory conditions is used to assess acute inflammation and monitor the effects of prolonged fasting and plant-based nutrition. Higher scores indicate more inflammation.
Creatinine in µmol per liter (µmol/L)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Biomarker of renal function and muscle metabolism.
Ketone bodies (mmol/l)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Indicators of fat metabolism and ketosis, analyzed for metabolic adaptations.
Glucose (mg/dl)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Fasting blood sugar measurement to monitor metabolic changes.
Hepatic transaminases (ALAT, ASAT)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	* ALAT in units per liter (U/L); * ASAT (U/L)
Electrolytes	Date of inclusion (baseline), day 8, after 6 and 12 weeks	* calcium in millimol per liter (mmol/L); * potassium (mmol/L); * sodium (mmol/L)
Flow cytometry: Phenotyping of immune cells	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Determination of cytometric parameters to assess changes in cell activation and quantify alterations in the absolute and/or relative sizes of immune cell subpopulations (e.g., classical, intermediate, and non-classical monocytes; naïve and memory T-cells; B-cell differentiation to plasmablasts and plasma cells). In addition, gene expression analysis of immune cells using Affymetrix whole genome microarrays and RNA sequencing (RNAseq) will be conducted to explore transcriptional patterns and identify markers that could reveal relevant immune cell subpopulations, which are not yet captured in the cytometric phenotyping screen.
Cytokine profile	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Quantification of pro- and anti-inflammatory cytokines (e.g., IL-6, IL-17, TNF-α, IL-10) using multiplex ELISA or Luminex technology.
Functional immune cell tests	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Ex vivo stimulation of immune cells to measure proliferation capacity and cytokine secretion.
NK cell activity	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Determination of cytotoxic function of natural killer (NK) cells.
Autoantibodies	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Screening for disease-relevant autoantibodies associated with immune dysregulation.
Gene expression analysis	Date of inclusion (baseline), day 8, after 6 and 12 weeks	RNA sequencing of whole blood samples to assess diet-induced transcriptomic changes.
Epigenetic analysis	Date of inclusion (baseline), day 8, after 6 and 12 weeks	DNA methylation profiling to examine nutrition-related epigenetic modifications.
Metabolomics	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Targeted and untargeted metabolite profiling of energy, lipid, and amino acid metabolism.
Biobanking (for future proteomics analysis)	Date of inclusion (baseline), day 8, after 6 and 12 weeks	Sample storage for additional protein analysis if funding is secured.
Gut microbiota characterization	Date of inclusion (baseline), day 8 or first stool after fasting, after 6 and 12 weeks	Molecular profiling of the highly individualized intestinal microbiota composition is performed through 16S rDNA gene sequencing of stool samples, aiming to identify fasting- and diet-induced alterations in the gut microbiota.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum; 🇩🇪 Berlin, Germany