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PsoriasisNCT06574178

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

A study testing Dietary Counseling in people with Psoriasis, run by University of California, Davis at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Dietary Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 1 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Salsala Nasim, BS contact

9165512636

sanasim@ucdavis.edu

Samuel T Hwang, MD, PhD contact

9165512610

sthwang@ucdavis.edu

United States1 site, 1 recruiting

  • University of California, Davis - Dermatology Department

    Sacramento, California, 95816

    Salsala Nasim, BS, 916-551-2636, sanasim@ucdavis.edu

    Samuel T Hwang, MD, PhD, 916-551-2610, sthwang@ucdavis.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Psoriasis is a chronic inflammatory disease that affects the skin and joints of up to 2-3% of the US population and well known to be associated with multiple medical co-morbidities, including cardiac disease, type 2 diabetes, and obesity. Skin, joint, vascular and organ inflammation has been measured in patients with psoriasis using older PET imaging methodologies4,5 and correlated with disease6. The Hwang lab has shown that mice triggered with systemic exposure to IL-23, a known pathogenic cytokine in human psoriasis, will develop PET-detectable signs of inflammation in joints, and, that this PET signal is greatly diminished by an antagonist of CCR6, a chemokine receptor believed to play a key role in Th17 cell migration7.

Dietary patterns containing high amounts of saturated fat, added sugars, and low in dietary fiber - also known as Western diet (WD)- are thought to be a major contributor to the epidemic of obesity worldwide. The Hwang lab has recently also shown that mice fed a WD show histologic, clinical, and molecular signs of psoriasis within 4 weeks8 which are accompanied by striking changes in the gut microbiome9. In addition, the WD accentuates IL-23-mediated skin and joint inflammation in mice, which is partially reversible when the animals are then placed on a conventional balanced diet9. Data from studies in humans support that weight loss may be an effective adjunct to medical treatment to ameliorate signs and symptoms of psoriasis, prompting the National Psoriasis Foundation to strongly recommend caloric restriction to achieve weight loss in obese psoriatic patients10. However, the role of diet composition/quality in psoriasis-related outcomes remains currently poorly understood. To this end, the overarching goal of this pilot study is to determine whether or not a 6-week dietary intervention that follows the current nutrition guidelines for chronic disease prevention (healthy diet)11-13 can affect psoriasis-related outcomes in patients with psoriasis who generally consume a WD.

These published studies lead us to hypothesize that dietary intervention, even in as little as 6 weeks, will reduce PET-measurable skin and systemic signs of inflammation in patients with psoriasis who habitually consume a WD that is high in fat and sugar content.

The EXPLORER scanner is unique because it has: (i) an axial field of view of 194 cm that covers the entire adult human body in a single bed position; (ii) increased detection efficiency (by a factor of ~40) for whole-body PET imaging compared to standard scanners, thus enabling dose reduction and/or faster scanning; and (iii) a PET spatial resolution (~3 mm) that significantly exceeds that of most current whole-body PET/CT scanners. The investigators believe that this technology has potential to overcome limitations of current PET/CT technology and significantly positively impact patient assessment.

Given the speed, whole-body coverage, and spatial resolution of the Total-body PET EXPLORER scanner at UC Davis, the investigators propose to test this hypothesis by quantitatively assessing uptake of 18F-FDG in recruited patients before dietary intervention and then 6 weeks later after intervention with a nutritionally recommended diet. Normal, healthy controls who have had previous scans performed under the same protocol will be available for comparative purposes. If several of the planned enrollment of 5 patients show demonstrable decreases in systemic inflammation, the preliminary pilot data will be vital to support an application for NIH R-type grant to explore the use of total-body PET imaging to assess systemic inflammation in psoriatic patients as well as to justify the clinical need for dietary interventions in what are considered autoimmune diseases.

Conditions
Psoriasis
Being tested
Dietary Counseling
Keywords
western diet, Total-body PET
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary CounselingBehavioural

    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.

Study groups in NCT06574178
Study groupRoleWhat they receive
Dietary InterventionExperimentalParticipants will receive breakfast, lunch, and dinner in the form of fully cooked, ready-to-heat standardized meals for 6 weeks that are prepared by a commercial kitchen.
Receives: Behavioral: Dietary Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: in Week 0 and Week 6

Secondary outcomes (3)

  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)

    Measured: in Week 0 and Week 6

  2. Serum Inflammatory Markers

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

    Measured: 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.

    Measured: in Week 0 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574178
Sponsor's protocol ID
1912111
Status last verified
Jun 2026
First submitted
15 Aug 2024
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang X, Badawi RD, Cherry SR, Qi J. Theoretical study of the benefit of long axial field-of-view PET on region of interest quantification. Phys Med Biol. 2018 Jun 27;63(13):135010. doi: 10.1088/1361-6560/aac815.

    PubMed 29799814

  • Badawi R, Liu W, Berg E, et al. Progress on the EXPLORER project: towards a total body PET scanner for human imaging. J Nucl Med. 2018;59(supplement 1):223-223. http://jnm.snmjournals.org/content/59/supplement_1/223.short#cited-by.

  • Cherry SR, Badawi RD, Karp JS, Moses WW, Price P, Jones T. Total-body imaging: Transforming the role of positron emission tomography. Sci Transl Med. 2017 Mar 15;9(381):eaaf6169. doi: 10.1126/scitranslmed.aaf6169.

    PubMed 28298419

  • Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.

    PubMed 21576552

  • Chaudhari AJ, Ferrero A, Godinez F, Yang K, Shelton DK, Hunter JC, Naguwa SM, Boone JM, Raychaudhuri SP, Badawi RD. High-resolution (18)F-FDG PET/CT for assessing disease activity in rheumatoid and psoriatic arthritis: findings of a prospective pilot study. Br J Radiol. 2016 Jul;89(1063):20160138. doi: 10.1259/bjr.20160138. Epub 2016 Apr 25.

    PubMed 27109738

  • Naik HB, Natarajan B, Stansky E, Ahlman MA, Teague H, Salahuddin T, Ng Q, Joshi AA, Krishnamoorthy P, Dave J, Rose SM, Doveikis J, Playford MP, Prussick RB, Ehrlich A, Kaplan MJ, Lockshin BN, Gelfand JM, Mehta NN. Severity of Psoriasis Associates With Aortic Vascular Inflammation Detected by FDG PET/CT and Neutrophil Activation in a Prospective Observational Study. Arterioscler Thromb Vasc Biol. 2015 Dec;35(12):2667-76. doi: 10.1161/ATVBAHA.115.306460. Epub 2015 Oct 8.

    PubMed 26449753

  • Shi Z, Garcia-Melchor E, Wu X, Getschman AE, Nguyen M, Rowland DJ, Wilson M, Sunzini F, Akbar M, Huynh M, Law T, Raychaudhuri SK, Raychaudhuri SP, Volkman BF, Millar NL, Hwang ST. Targeting the CCR6/CCL20 Axis in Entheseal and Cutaneous Inflammation. Arthritis Rheumatol. 2021 Dec;73(12):2271-2281. doi: 10.1002/art.41882. Epub 2021 Nov 1.

    PubMed 34081845

  • Shi Z, Wu X, Yu S, Huynh M, Jena PK, Nguyen M, Wan YY, Hwang ST. Short-Term Exposure to a Western Diet Induces Psoriasiform Dermatitis by Promoting Accumulation of IL-17A-Producing gammadelta T Cells. J Invest Dermatol. 2020 Sep;140(9):1815-1823. doi: 10.1016/j.jid.2020.01.020. Epub 2020 Feb 10.

    PubMed 32057839

  • Shi Z, Wu X, Santos Rocha C, Rolston M, Garcia-Melchor E, Huynh M, Nguyen M, Law T, Haas KN, Yamada D, Millar NL, Wan YY, Dandekar S, Hwang ST. Short-Term Western Diet Intake Promotes IL-23-Mediated Skin and Joint Inflammation Accompanied by Changes to the Gut Microbiota in Mice. J Invest Dermatol. 2021 Jul;141(7):1780-1791. doi: 10.1016/j.jid.2020.11.032. Epub 2021 Jan 22.

    PubMed 33485880

  • Ford AR, Siegel M, Bagel J, Cordoro KM, Garg A, Gottlieb A, Green LJ, Gudjonsson JE, Koo J, Lebwohl M, Liao W, Mandelin AM 2nd, Markenson JA, Mehta N, Merola JF, Prussick R, Ryan C, Schwartzman S, Siegel EL, Van Voorhees AS, Wu JJ, Armstrong AW. Dietary Recommendations for Adults With Psoriasis or Psoriatic Arthritis From the Medical Board of the National Psoriasis Foundation: A Systematic Review. JAMA Dermatol. 2018 Aug 1;154(8):934-950. doi: 10.1001/jamadermatol.2018.1412.

    PubMed 29926091

  • Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kotchen TA, Lichtenstein AH, Mitch WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000 Oct 31;102(18):2284-99. doi: 10.1161/01.cir.102.18.2284. No abstract available.

    PubMed 11056107

  • American Diabetes Association. 4. Lifestyle Management: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S38-S50. doi: 10.2337/dc18-S004.

    PubMed 29222375

  • Subar AF, Thompson FE, Kipnis V, Midthune D, Hurwitz P, McNutt S, McIntosh A, Rosenfeld S. Comparative validation of the Block, Willett, and National Cancer Institute food frequency questionnaires : the Eating at America's Table Study. Am J Epidemiol. 2001 Dec 15;154(12):1089-99. doi: 10.1093/aje/154.12.1089.

    PubMed 11744511

  • Kennedy ET, Ohls J, Carlson S, Fleming K. The Healthy Eating Index: design and applications. J Am Diet Assoc. 1995 Oct;95(10):1103-8. doi: 10.1016/S0002-8223(95)00300-2.

    PubMed 7560680

  • Webb VL, Wadden TA. Intensive Lifestyle Intervention for Obesity: Principles, Practices, and Results. Gastroenterology. 2017 May;152(7):1752-1764. doi: 10.1053/j.gastro.2017.01.045. Epub 2017 Feb 10.

    PubMed 28192109

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Counseling in people with Psoriasis, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Salsala Nasim, BS (9165512636, sanasim@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammation in PET/CT scan (time frame: in Week 0 and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574178, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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