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Behavioral Intervention
Nutritionally Balanced Diet for Psoriasis
N/A
Recruiting
Led By Samuel T Hwang, MD, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients will have a BMI of >27
Be older than 18 years old
Must not have
Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiotracer injection
Inability to understand the risks and benefits of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in week 0 and week 6
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if a new PET scanner technology called EXPLORER is better at measuring inflammation in patients with psoriasis compared to older scanners. Researchers also want to see if switching from a
Who is the study for?
This trial is for people with psoriasis, a skin and joint condition. Participants should be those typically consuming a Western Diet high in saturated fats and sugars. The study will use the EXPLORER PET scanner to measure changes in their inflammation after switching to a balanced diet.
What is being tested?
The trial is testing if a nutritionally balanced diet can reduce systemic and cutaneous (skin) inflammation in psoriasis patients. It involves dietary counseling and uses advanced EXPLORER PET scanning technology to quantify inflammation before and after the dietary intervention.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include typical reactions to diet adjustment such as digestive discomfort or food cravings but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 27.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood sugar is not higher than 180 mg/dl and my diabetes is under control.
Select...
I understand the risks and benefits of the study.
Select...
I am on medication for diabetes.
Select...
I can't stay still on a scanner bed for up to 60 minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in week 0 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in week 0 and week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Inflammation in PET/CT scan
Secondary study objectives
Cell Surface Inflammatory Markers
Microbiomes Diversity
Serum Inflammatory Markers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dietary InterventionExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Counseling
2011
Completed Phase 3
~2050
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,683 Total Patients Enrolled
6 Trials studying Psoriasis
798 Patients Enrolled for Psoriasis
Samuel T Hwang, MD, PhDPrincipal InvestigatorUC Davis SOM Department of Dermatology
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