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

NCT06905028 | Recruiting

• 1 other identifier: RiseFast
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis Arthritis; Psoriasis (PsO)

Keywords

fasting; vegan; plant-based; diet; psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (45)

• 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

Other Outcomes (1)

• Final questionnaire to record tolerability of fasting and nutrition, adverse effects

  After 12 weeks

Study Arms (1)

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.

Other: Fasting and Plant-Based Diet

Interventions

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.

Fasting and Plant-Based Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Max Delbrück Center for Molecular Medicine (MDC), Berlin: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin, Psoriasis-Forschungs- und BehandlungsCentrum

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Psoriasis; Fasting

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Anika Rajput Khokhar, MD

CONTACT

+49 30 450 518 329; risefast@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)