The Impact of Fasting on Disease Activity and the Gut Microbiota in Patients With Psoriasis and Psoriatic Arthritis - the RiseFast Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Fasting and Plant-Based Diet (Other)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI)
时间窗: 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)
时间窗: 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.
次要结局
- Body Mass Index (kg/m2)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Creatinine in µmol per liter (µmol/L)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Cytokine profile(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Functional immune cell tests(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Metabolomics(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Sociodemographic Measurements(Date of inclusion (baseline))
- Medication intake(Date of inclusion (baseline), after 6 and 12 weeks)
- Quantification of Behavioral Factors(Date of inclusion (baseline), after 6 and 12 weeks)
- Behavioral Factors: alcohol consumption(Date of inclusion (baseline), after 6 and 12 weeks)
- Behavioral Factors: smoking(Date of inclusion (baseline), after 6 and 12 weeks)
- Expectation questions(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)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Bio-electrical impedance analysis (BIA)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Body Surface Area (BSA)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Nail Psoriasis Severity Index (NAPSI)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Criteria of minimal disease activity (MDA) or very low disease activity (VLDA)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- 68 Tender Joint Count(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- 66 Swollen Joint Count(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Leeds Enthesitis Index (LEI)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- ACR20/50 criteria(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Quality of Life questionnaire (WHO-5)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Dermatology Life Quality Index (DLQI)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- EULAR Psoriatic Arthritis Impact of Disease (PsAID12)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Subjective strength of the main complaint (Visual Analogue Scale)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Short Form 36(Date of inclusion (baseline) and after 12 weeks)
- Food selection(Date of inclusion (baseline), after 4 and 9 weeks)
- Dietary Behaviour(Date of inclusion (baseline), after 6 and 12 weeks)
- Differential blood count(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- CRP in milligram per liter (mg/L)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Ketone bodies (mmol/l)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Glucose (mg/dl)(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(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- NK cell activity(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Autoantibodies(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Gene expression analysis(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Epigenetic analysis(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Biobanking (for future proteomics analysis)(Date of inclusion (baseline), day 8, after 6 and 12 weeks)
- Gut microbiota characterization(Date of inclusion (baseline), day 8 or first stool after fasting, 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)
- 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)
- Lactate dehydrogenase (LDH) (U/L)(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)
- 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)
研究者
Anika Rajput, MD/PhD
Principal Investigator, Clinician Scientist
Charite University, Berlin, Germany