Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621927
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Ideal Food Pyramid on Gut Microbiota Disease Activity Body Composition and Biochemical Parameters in Rheumatoid Arthritis A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to observe the effects of the Ideal Food Pyramid created for Rheumatoid Arthritis patients on disease activity inflammatory markers body composition and intestinal microbiota The main questions it aims to answer are
Does the Ideal Food Pyramid improve dysbiosis in patients with rheumatoid arthritis
Does the Ideal Food Pyramid improve clinical and laboratory findings in patients with rheumatoid arthritis Researchers will compare the Ideal Food Pyramid with a control group no intervention to determine if it has an effect on rheumatoid arthritis
Participants
All participants will fill out questionnaires at the beginning of the study blood and stool will be collected These procedures will be repeated at the end of the study
Diet or control no intervention will be applied for 12 weeks Diet group will be checked for compliance with the diet every 2 weeks
Does the Ideal Food Pyramid improve dysbiosis in patients with rheumatoid arthritis
Does the Ideal Food Pyramid improve clinical and laboratory findings in patients with rheumatoid arthritis Researchers will compare the Ideal Food Pyramid with a control group no intervention to determine if it has an effect on rheumatoid arthritis
Participants
All participants will fill out questionnaires at the beginning of the study blood and stool will be collected These procedures will be repeated at the end of the study
Diet or control no intervention will be applied for 12 weeks Diet group will be checked for compliance with the diet every 2 weeks
Detailed Description:
This study will be conducted on patients diagnosed with Rheumatoid Arthritis who meet the inclusion criteria and apply to the Rheumatology Polyclinic of Erciyes University Faculty of Medicine Hospital Diagnosed patients will be directed to the Diet Polyclinic Patients who come to the polyclinic will be included in the study on a voluntary basis and the patients will sign an informed consent form A diet program based on the pyramid created for Rheumatoid arthritis patients will be created for each patient and will be followed for 12 weeks A questionnaire form containing questions about sociodemographic characteristics nutritional habits anthropometric measurements physical activity status and disease activity will be filled out by face-to-face interviews with the patients The questionnaire and scale forms used for disease activity and physical activity status are as follows DAS28 Disease Activity Score Simple Disease Activity Index SDAI Health Assessment Questionnaire HAQ International Physical Activity Questionnaire Short Visual Analog Scale VAS SF-36 Quality of Life Scale Short Form 36 Rheumatoid Arthritis Quality of Life Scale QOL-RA Fecal samples blood samples and anthropometric measurements will be taken from the volunteers before starting the study and twice at the end of 12 weeks and comparisons will be made before and after Fecal samples taken from individuals will be stored at -80C until the day of analysis for microbiota analysis The samples will be processed in the Metagenome laboratory at Erciyes University Genome and Stem Cell Center GENKÖK and sequenced using the 16s rRNA next generation sequencing method The obtained data will be analyzed in detail with an artificial intelligence algorithm and reported Blood will be taken from individuals after 10-12 hours of fasting Fasting blood glucose mgdl C reactive protein CRP sedimentation rate mms triglyceride mgdl cholesterol mgdl HDL cholesterol mgdl LDL cholesterol mgdl urea mgdl creatinine mgdl uric acid mgdl complete blood count hemogram aspartate aminotransferase AST IUL alanine aminotransferase ALT IUL values will be checked at Erciyes University Central Laboratory
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None