At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Role of Intermittent Fasting on Disease Severity and Quality of Life in Psoriasis and Psoriatic Arthritis
In Brief
A clinical study evaluating Intermittent Fasting Diet for Psoriasis and Psoriatic Arthritis. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Our study aims to determine whether intermittent fasting (IMF) is a valid method to improve psoriasis and psoriatic arthritis (PsA) disease severity and quality of life. Patients within OSU Dermatology with psoriasis and/or psoriatic arthritis will be enrolled in a dietary intervention for a 24-week period. A prospective, single-blind parallel group randomized control trial will include an IMF dietary intervention group and a standard routine diet group for a duration of 24 weeks. After the initial 12 weeks of the dietary intervention, patients will be followed for an additional 12 weeks to assess changes in their disease state and quality of life after returning to their initial dietary routines. In total, the study will be 24 weeks. Baseline assessment will consist of standard psoriasis and PsA clinical parameters; evaluation will be performed by a blinded physician. These parameters will be reassessed every 4 weeks via video visit for the three month duration of the study, and then again at the 24-week conclusion of the study. In addition, each visit will assess patient-reported outcomes using dermatology-specific quality of life indices. Biometric measurements of weight, height, BMI, and waist-to-hip ratio will be recorded at baseline and all subsequent visits. Dietary adherence will be assessed by virtual check-in visits, and dietary guidance will be provided and reviewed at each visit by the research coordinator. A physician or the research coordinator will be available for questions between times of data collection. The primary outcome measure will be feasibility of a larger study, which will be determined at the initial 12-week timepoint. This data is vital to determine effect size and dropout frequency for future studies. Secondary outcomes will include changes in clinical indices, biometric measurements, and quality of life indices at 12 weeks after randomization and at the end of the 24-week study. Achievement of a 5% weight reduction at 12 weeks, and a 10-15% weight reduction at 24 weeks will be additional secondary endpoints. Data for each patient will be stored in a password-protected and encrypted REDCAP database on a secure OSU server.
Study Details
Timeline
Interventions
Patients will follow the 16: 8 traditional intermittent fasting model, where they may only consume calories during 1 continuous 8-hour period of the day. Water may be consumed during fasting.