RecruitingNot ApplicableNCT06905028

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

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


Sponsor

Charite University, Berlin, Germany

Enrollment

30 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

OTHERFasting 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.


Locations(1)

Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum

Berlin, State of Berlin, Germany

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NCT06905028


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