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

March 25, 2025 updated by: Anika Rajput Khokhar, Charite University, Berlin, Germany

The Impact of Fasting on Disease Activity and the Gut Microbiota in Patients with Psoriasis and Psoriatic Arthritis - the RiseFast Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fasting and Plant-Based Diet
The participants (n=15 with PsO, n=15 with PsA) will undergo an initial 7-day fasting regime according to Buchinger (max. 350 kcal per day as liquids), followed by a dietary intervention that encompasses a plant-based diet (PBD) and time restricted eating (TRE) for 11 weeks.
Other: Fasting and Plant-Based Diet
The participants will undergo an initial 7-day fasting regime according to Buchinger (max. 350 kcal per day as liquids), followed by a dietary intervention that encompasses a plant-based diet (PBD) and time restricted eating (TRE) for 11 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Disease Activity index for PSoriatic Arthritis (DAPSA)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic Measurements
Time Frame: 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.
Date of inclusion (baseline)
Medication intake
Time Frame: Date of inclusion (baseline), after 6 and 12 weeks
Systematized documentation of medication, main and secondary diagnoses using CRF.
Date of inclusion (baseline), after 6 and 12 weeks
Quantification of Behavioral Factors
Time Frame: 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.
Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: alcohol consumption
Time Frame: Date of inclusion (baseline), after 6 and 12 weeks
Number of alcoholic beverages on average per week in the last month.
Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: smoking
Time Frame: Date of inclusion (baseline), after 6 and 12 weeks
Smoking status in packyears.
Date of inclusion (baseline), after 6 and 12 weeks
Expectation questions
Time Frame: Date of inclusion (baseline)
For fasting on a 10-point likert scale from 1 (nothing at all) to 10 (very strong).
Date of inclusion (baseline)
Resting blood pressure (mmHg)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Pulse rate (bmp)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Abdominal circumference (cm)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Waist to Hip Ratio (cm)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Weight (kg)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Change in weight (kg)
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Body Mass Index (kg/m2)
Time Frame: 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)
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Time Frame: 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 %)
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Body Surface Area (BSA)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Nail Psoriasis Severity Index (NAPSI)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Criteria of minimal disease activity (MDA) or very low disease activity (VLDA)
Time Frame: 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
Date of inclusion (baseline), day 8, after 6 and 12 weeks
68 Tender Joint Count
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
66 Swollen Joint Count
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Leeds Enthesitis Index (LEI)
Time Frame: 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).
Date of inclusion (baseline), day 8, after 6 and 12 weeks
ACR20/50 criteria
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Quality of Life questionnaire (WHO-5)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Dermatology Life Quality Index (DLQI)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
EULAR Psoriatic Arthritis Impact of Disease (PsAID12)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Subjective strength of the main complaint (Visual Analogue Scale)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Short Form 36
Time Frame: 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).
Date of inclusion (baseline) and after 12 weeks
Food selection
Time Frame: Date of inclusion (baseline), after 4 and 9 weeks
Nutritional history via dietary record (3-day food record)
Date of inclusion (baseline), after 4 and 9 weeks
Dietary Behaviour
Time Frame: 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.
Date of inclusion (baseline), after 6 and 12 weeks
Differential blood count
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
CRP in milligram per liter (mg/L)
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Creatinine in µmol per liter (µmol/L)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Biomarker of renal function and muscle metabolism.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Ketone bodies (mmol/l)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Indicators of fat metabolism and ketosis, analyzed for metabolic adaptations.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Glucose (mg/dl)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Fasting blood sugar measurement to monitor metabolic changes.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Hepatic transaminases (ALAT, ASAT)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
  • ALAT in units per liter (U/L)
  • ASAT (U/L)
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Electrolytes
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
  • calcium in millimol per liter (mmol/L)
  • potassium (mmol/L)
  • sodium (mmol/L)
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Flow cytometry: Phenotyping of immune cells
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Cytokine profile
Time Frame: 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.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Functional immune cell tests
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Ex vivo stimulation of immune cells to measure proliferation capacity and cytokine secretion.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
NK cell activity
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Determination of cytotoxic function of natural killer (NK) cells.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Autoantibodies
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Screening for disease-relevant autoantibodies associated with immune dysregulation.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Gene expression analysis
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
RNA sequencing of whole blood samples to assess diet-induced transcriptomic changes.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Epigenetic analysis
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
DNA methylation profiling to examine nutrition-related epigenetic modifications.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Metabolomics
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Targeted and untargeted metabolite profiling of energy, lipid, and amino acid metabolism.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Biobanking (for future proteomics analysis)
Time Frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Sample storage for additional protein analysis if funding is secured.
Date of inclusion (baseline), day 8, after 6 and 12 weeks
Gut microbiota characterization
Time Frame: 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.
Date of inclusion (baseline), day 8 or first stool after fasting, after 6 and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final questionnaire to record tolerability of fasting and nutrition, adverse effects
Time Frame: After 12 weeks
Measurement of tolerability of fasting and nutrition as well as adverse effects via Likert Scales, range from 0 to 10 while higher values meaning a higher grade of agreement.
After 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Max Delbrück Center for Molecular Medicine (MDC), Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiseFast

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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