Assessing Inflammation in Psoriasis Patients Using Advanced PET Scanning and Diet Changes
Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet
This study is testing if a new type of PET scan can measure inflammation in psoriasis patients and if changing to a healthier diet for six weeks can help reduce that inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06574178 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the new EXPLORER PET scanner technology in measuring systemic and cutaneous inflammation in psoriasis patients. Participants will follow a nutritionally balanced diet for six weeks, transitioning from a typical Western diet, to determine if this dietary change leads to a reduction in inflammation detectable by the EXPLORER PET scan. The study aims to correlate dietary patterns with inflammation levels, potentially providing insights into dietary interventions for managing psoriasis. The research will involve both imaging and dietary assessments to gather comprehensive data on the participants' health.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a history of psoriasis affecting at least 3% of their body surface area and a BMI of 25 or higher, who typically consume a Western diet.
Not a fit: Patients currently taking anti-diabetic medications or those with a well-balanced diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that dietary changes can significantly reduce inflammation in psoriasis patients, leading to improved management of the condition.
How similar studies have performed: While dietary interventions have been explored in other studies, the use of the EXPLORER PET scanner for this specific purpose is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (\>18 year) * Both sexes * Must have a history of psoriasis of at least 3% body surface area affected by skin psoriasis (in a body area that the subject will allow the PI to perform several skin biopsies as noted below (optional)) and may carry a diagnosis of psoriatic arthritis as well * Patients will have a BMI of \>/=25 which is consistent with being overweight - Willing and able to fast for at least 6 hours before and for the duration of the scan visit * No strenuous exercise for 24 hours prior to being scanned * Recruited patients must habitually consume a WD-type diet that will be evaluated by using DHQ III food frequency questionnaire along with three-day food record14. Subsequently, the Healthy Eating Index will be calculated and participants with a poor dietary pattern (score below 58) will be eligible for the study15. Exclusion Criteria: * Those taking anti-diabetic oral or injected medications * Those already ingesting a caloric- or component-restricted diet * Vegan, vegetarian or food allergy or intolerance to the ingredients of the diet * \>5% change in body weight in the last 2 months * Those taking systemic medications for the purpose of treating psoriasis or psoriatic arthritis for at least 3 months prior to first PET scan or during the duration of the trial * Self-reported history of dysphoria or anxiety in closed spaces (claustrophobia) * Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiotracer injection * Body weight \>240 kg due to limitations of the scanner bed * Known inflammatory or other infectious disease that can confound assessment * Pregnant or breast-feeding (urine pregnancy test will be administered prior to start of each PET/CT session for all participants who are able to get pregnant between 18 to 60 years old, unless documented hysterectomy or bilateral ovarian removal is available, because of risks from ionizing radiation) * Inability to lie motionless on the scanner bed with the arms by the side for up to 60 minutes * Currently participating in another conflicting research study. Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. * Unwilling to sign informed consent * Inability to understand the risks and benefits of the study * Prisoners
Where this trial is running
Sacramento, California
- University of California, Davis - Dermatology Department — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Samuel T Hwang, MD, PhD — UC Davis SOM Department of Dermatology
- Study coordinator: Salsala Nasim, BS
- Email: sanasim@ucdavis.edu
- Phone: 9165512636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.