NCT06574178 Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet
| NCT ID | NCT06574178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-01-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients. Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet.
Eligibility 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
Contact & Investigator
Samuel T Hwang, MD, PhD
PRINCIPAL INVESTIGATOR
UC Davis SOM Department of Dermatology
Frequently Asked Questions
Who can join the NCT06574178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06574178 currently recruiting?
Yes, NCT06574178 is actively recruiting participants. Contact the research team at sanasim@ucdavis.edu for enrollment information.
Where is the NCT06574178 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06574178 clinical trial?
NCT06574178 is sponsored by University of California, Davis. The principal investigator is Samuel T Hwang, MD, PhD at UC Davis SOM Department of Dermatology. The trial plans to enroll 5 participants.
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