RECRUITING

Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet

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Psoriasiswestern dietTotal-body PET

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet

Quick Facts

Study Start:2025-01-01
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06574178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (\>18 year)
  2. * Both sexes
  3. * 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
  4. * 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
  5. * No strenuous exercise for 24 hours prior to being scanned
  6. * 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.
  1. * Those taking anti-diabetic oral or injected medications
  2. * Those already ingesting a caloric- or component-restricted diet
  3. * Vegan, vegetarian or food allergy or intolerance to the ingredients of the diet
  4. * \>5% change in body weight in the last 2 months
  5. * 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
  6. * Self-reported history of dysphoria or anxiety in closed spaces (claustrophobia)
  7. * Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiotracer injection
  8. * Body weight \>240 kg due to limitations of the scanner bed
  9. * Known inflammatory or other infectious disease that can confound assessment
  10. * 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)
  11. * Inability to lie motionless on the scanner bed with the arms by the side for up to 60 minutes
  12. * 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.
  13. * Unwilling to sign informed consent
  14. * Inability to understand the risks and benefits of the study
  15. * Prisoners

Contacts and Locations

Study Contact

Salsala Nasim, BS
CONTACT
9165512636
sanasim@ucdavis.edu
Samuel T Hwang, MD, PhD
CONTACT
9165512610
sthwang@ucdavis.edu

Principal Investigator

Samuel T Hwang, MD, PhD
PRINCIPAL_INVESTIGATOR
UC Davis SOM Department of Dermatology

Study Locations (Sites)

University of California, Davis - Dermatology Department
Sacramento, California, 95816
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Samuel T Hwang, MD, PhD, PRINCIPAL_INVESTIGATOR, UC Davis SOM Department of Dermatology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • western diet
  • Total-body PET

Additional Relevant MeSH Terms

  • Psoriasis