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

ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dietary Counseling

    Behavioral

    A Registered Dietitian or Nutritionist will provide nutrition education either in person, over the phone, or via Zoom. The behavioral program will use cognitive-behavioral techniques to foster adherence to diet prescriptions and to build a supportive environment for the participant.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Dietary InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Inflammation in PET/CT scan

measuring inflammation in PET imaging by calculating the maximum standardized uptake values (SUVmax) in given areas of interest (e.g., joint, blood vessel)

Time frame
in Week 0 and Week 6

Secondary outcomes

1

Microbiomes Diversity

Measuring changes in stool and skin microbiome both through alpha diversity analysis measured in operational taxonomic units, and through beta diversity analysis using unweighted UniFrac Distance Principal Coordinates Analysis Plots (Shi et al.,2021)

Time frame
in Week 0 and Week 6
2

Serum Inflammatory Markers

measuring TNF, IL-17A, and CRP levels through ELISA methods in blood samples

Time frame
in Week 0 and Week 6
3

Cell Surface Inflammatory Markers

measuring cell surface integrin, L-selectin, CD11b, and CD66b levels by standard flow cytometric methods in blood samples.

Time frame
in Week 0 and Week 6

Other outcomes

Sponsors and contacts

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