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| Name | Class |
|---|---|
| Max Delbrück Center for Molecular Medicine (MDC), Berlin | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting and Plant-Based Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Date of inclusion (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Final questionnaire to record tolerability of fasting and nutrition, adverse effects | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005247 | Feeding Behavior |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Medication intake |
Systematized documentation of medication, main and secondary diagnoses using CRF. |
| 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. | 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. | Date of inclusion (baseline), after 6 and 12 weeks |
| Behavioral Factors: smoking | Smoking status in packyears. | 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). | Date of inclusion (baseline) |
| 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) | Change in weight (kg) | 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) | 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 %) | 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. | 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. | 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 | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Date of inclusion (baseline) and after 12 weeks |
| Food selection | Nutritional history via dietary record (3-day food record) | 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. | 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. | 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. | 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. | 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. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Glucose (mg/dl) | Fasting blood sugar measurement to monitor metabolic changes. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Hepatic transaminases (ALAT, ASAT) and Gamma glutamyl transpeptidase (y-GT) |
| Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Electrolytes |
| 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. | 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. | 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. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| NK cell activity | Determination of cytotoxic function of natural killer (NK) cells. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Autoantibodies | Screening for disease-relevant autoantibodies associated with immune dysregulation. | 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. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Epigenetic analysis | DNA methylation profiling to examine nutrition-related epigenetic modifications. | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Metabolomics | Targeted and untargeted metabolite profiling of energy, lipid, and amino acid metabolism.
| Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Creatine kinase (U/L) | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Uric acid (µmol/L) | 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. | 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. | Date of inclusion (baseline), day 8 or first stool after fasting, after 6 and 12 weeks |
| Lactate dehydrogenase (LDH) (U/L) | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Serum Vitamin B12 Levels (ng/l) | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min) | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Total protein in grams per liter (g/L) | 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 | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| Albumin in grams per liter (g/L) | Date of inclusion (baseline), day 8, after 6 and 12 weeks |
| D001519 | Behavior |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |