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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339957
Other study ID # STUDY00006394
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date July 1, 2024

Study information

Verified date March 2024
Source University of Central Florida
Contact Amoy Fraser, PhD, CCRP, PMP
Phone 407-266-8742
Email amoy.fraser@ucf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adults (over 18 years old) patients - established UCF Health patients - diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, dermatomyositis/polymyositis, Sjogren's Syndrome, systemic lupus erythematous, scleroderma, osteoarthritis, or fibromyalgia. Exclusion Criteria: - UCF Students, Faculty or Staff - Children or Young Adults Under the age of 18 - Adults over 65 - Pregnant Women - Prisoners - Adults to Unable to Consent

Study Design


Locations

Country Name City State
United States UCF Health Clinics Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine how diet habits and activity affects autoimmune diseases using the proper statistical tests for the data set such as t-test and ANOVA. 4 months
Secondary To identify if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. 4 months
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