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

NCT06574178 | Recruiting

• 1 other identifier: 1912111
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

western diet; Total-body PET

Outcome Measures

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)

  in Week 0 and Week 6

Secondary Outcomes (3)

• Microbiomes Diversity

  in Week 0 and Week 6

• Serum Inflammatory Markers

  in Week 0 and Week 6

• Cell Surface Inflammatory Markers

  in Week 0 and Week 6

Study Arms (1)

Dietary Intervention

EXPERIMENTAL

Participants 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.

Behavioral: Dietary Counseling

Interventions

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.

Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 29799814 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28298419 BACKGROUND

• 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.

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• 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.

  PMID: 26449753 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 33485880 BACKGROUND

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  PMID: 28944593 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Samuel T Hwang, MD, PhD

  UC Davis SOM Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salsala Nasim, BS

CONTACT

9165512636; sanasim@ucdavis.edu

Samuel T Hwang, MD, PhD

CONTACT

9165512610; sthwang@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)