Psoriasis ArthritisNCT06905028
Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)
A study testing Fasting and Plant-Based Diet in people with Psoriasis Arthritis and Psoriasis (PsO), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Arthritis, Psoriasis (PsO)
- What is being tested?
- Fasting and Plant-Based Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 4 Apr 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum
Berlin, State of Berlin, 10117
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis Arthritis, Psoriasis (PsO)
- Being tested
- Fasting and Plant-Based Diet
- Keywords
- fasting, vegan, plant-based, diet, psoriasis
- Medical subject headings
- Psoriasis, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting and Plant-Based DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting and Plant-Based Diet | Other | 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. Receives: Other: Fasting and Plant-Based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
Changes in disease activity measured by the Psoriasis Area and Severity Index (PASI) after 12 weeks compared to baseline.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Disease Activity index for PSoriatic Arthritis (DAPSA)
Changes in disease activity measured by the Disease Activity index for Psoriatic Arthritis (DAPSA) after 12 weeks compared to baseline.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Secondary outcomes (53)
Sociodemographic Measurements
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.
Measured: Date of inclusion (baseline)
Medication intake
Systematized documentation of medication, main and secondary diagnoses using CRF.
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Quantification of Behavioral Factors
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.
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: alcohol consumption
Number of alcoholic beverages on average per week in the last month.
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: smoking
Smoking status in packyears.
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Expectation questions
For fasting on a 10-point likert scale from 1 (nothing at all) to 10 (very strong).
Measured: Date of inclusion (baseline)
Resting blood pressure (mmHg)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Pulse rate (bmp)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Abdominal circumference (cm)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Waist to Hip Ratio (cm)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Weight (kg)
Change in weight (kg)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Body Mass Index (kg/m2)
Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Bio-electrical impedance analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Body Surface Area (BSA)
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Nail Psoriasis Severity Index (NAPSI)
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Criteria of minimal disease activity (MDA) or very low disease activity (VLDA)
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
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
68 Tender Joint Count
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
66 Swollen Joint Count
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Leeds Enthesitis Index (LEI)
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).
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
ACR20/50 criteria
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Health Assessment Questionnaire Disability Index (HAQ-DI)
Change from Baseline in the HAQ after 12 weeks, range from 0 to 3 while higher values meaning a higher grade of disability.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Quality of Life questionnaire (WHO-5)
Change from Baseline in the WHO-5, range from 0 to 100 %, higher values meaning a higher grade of well-being.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Dermatology Life Quality Index (DLQI)
Changes from Baseline in the DLQI after 12 weeks, range from 0 to 3, higher values meaning a lower grade of life quality.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
EULAR Psoriatic Arthritis Impact of Disease (PsAID12)
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Subjective strength of the main complaint (Visual Analogue Scale)
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Short Form 36
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).
Measured: Date of inclusion (baseline) and after 12 weeks
Food selection
Nutritional history via dietary record (3-day food record)
Measured: Date of inclusion (baseline), after 4 and 9 weeks
Dietary Behaviour
The Food Frequency Questionnaire (FFQ) records dietary behaviors such as mealtimes, frequency of food intake, food preferences, and fasting experiences.
Measured: Date of inclusion (baseline), after 6 and 12 weeks
Differential blood count
Analysis of different types of blood cells to assess immune status and detect possible infections or inflammations.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
CRP in milligram per liter (mg/L)
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Creatinine in µmol per liter (µmol/L)
Biomarker of renal function and muscle metabolism.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Ketone bodies (mmol/l)
Indicators of fat metabolism and ketosis, analyzed for metabolic adaptations.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Glucose (mg/dl)
Fasting blood sugar measurement to monitor metabolic changes.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Hepatic transaminases (ALAT, ASAT) and Gamma glutamyl transpeptidase (y-GT)
- ALAT in units per liter (U/L)
- ASAT (U/L)
- gamma-GT (U/l)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Electrolytes
- calcium in millimol per liter (mmol/L)
- potassium (mmol/L)
- sodium (mmol/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Flow cytometry: Phenotyping of immune cells
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.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Cytokine profile
Quantification of pro- and anti-inflammatory cytokines (e.g., IL-6, IL-17, TNF-α, IL-10) using multiplex ELISA or Luminex technology.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Functional immune cell tests
Ex vivo stimulation of immune cells to measure proliferation capacity and cytokine secretion.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
NK cell activity
Determination of cytotoxic function of natural killer (NK) cells.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Autoantibodies
Screening for disease-relevant autoantibodies associated with immune dysregulation.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Gene expression analysis
RNA sequencing of whole blood samples to assess diet-induced transcriptomic changes.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Epigenetic analysis
DNA methylation profiling to examine nutrition-related epigenetic modifications.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Metabolomics
Targeted and untargeted metabolite profiling of energy, lipid, and amino acid metabolism.
- triglycerides (mg/dl)
- total cholesterol (mg/dl)
- LDL cholesterol (mg/dl)
- non-HDL cholesterol (mg/dl)
- HDL cholesterol (mg/dl)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Creatine kinase (U/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Uric acid (µmol/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Biobanking (for future proteomics analysis)
Sample storage for additional protein analysis if funding is secured.
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Gut microbiota characterization
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.
Measured: Date of inclusion (baseline), day 8 or first stool after fasting, after 6 and 12 weeks
Lactate dehydrogenase (LDH) (U/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Serum Vitamin B12 Levels (ng/l)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Total protein in grams per liter (g/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Serum 25-hydroxyvitamin D (25(OH)D) levels in nmol/l and Serum 1,25-Dihydroxyvitamin D [1,25(OH)2D3] levels in nmol/l
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Albumin in grams per liter (g/L)
Measured: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start4 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis ArthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine (MDC), Berlin
- Responsible party
- Principal investigator, Anika Rajput, MD/PhD, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905028
- Sponsor's protocol ID
- RiseFast
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fasting on Disease Activity and the Gut Microbiota in Patients With Psoriasis and Psoriatic Arthritis - the RiseFast Pilot Study
- ClinicalTrials.gov ID
- NCT06905028
- Acronym / sponsor ID
- RiseFast
- Conditions
- Psoriasis Arthritis, Psoriasis (PsO)
- Keywords
- fasting, vegan, plant-based, diet, psoriasis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Max Delbrück Center for Molecular Medicine (MDC), Berlin
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting and Plant-Based Diet | Other | Other: Fasting and Plant-Based DietThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting and Plant-Based DietThe 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. | Other | Fasting and Plant-Based Diet |
Primary outcome
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.
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.
53 secondary outcomes
Sociodemographic Measurements
Time frame: Date of inclusion (baseline)
Medication intake
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Quantification of Behavioral Factors
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: alcohol consumption
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Behavioral Factors: smoking
Time frame: Date of inclusion (baseline), after 6 and 12 weeks
Expectation questions
Time frame: Date of inclusion (baseline)
Resting blood pressure (mmHg)
Time frame: 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
Abdominal circumference (cm)
Time frame: 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
Weight (kg)
Time frame: 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
Bio-electrical impedance analysis (BIA)
Time frame: 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
Nail Psoriasis Severity Index (NAPSI)
Time frame: 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
68 Tender Joint Count
Time frame: 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
Leeds Enthesitis Index (LEI)
Time frame: 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
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 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
Dermatology Life Quality Index (DLQI)
Time frame: 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
Subjective strength of the main complaint (Visual Analogue Scale)
Time frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Short Form 36
Time frame: Date of inclusion (baseline) and after 12 weeks
Food selection
Time frame: Date of inclusion (baseline), after 4 and 9 weeks
Dietary Behaviour
Time frame: 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
CRP in milligram per liter (mg/L)
Time frame: 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
Ketone bodies (mmol/l)
Time frame: 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
Hepatic transaminases (ALAT, ASAT) and Gamma glutamyl transpeptidase (y-GT)
Time frame: 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
Flow cytometry: Phenotyping of immune cells
Time frame: 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
Functional immune cell tests
Time frame: 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
Autoantibodies
Time frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Plant-Based Diet in people with Psoriasis Arthritis and Psoriasis (PsO), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) (time frame: Date of inclusion (baseline), day 8, after 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.