The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis

NCT ID: NCT06621927

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-06-20

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

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 -80°C 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 (mg/dl), C reactive protein (CRP), sedimentation rate (mm/s), triglyceride (mg/dl), cholesterol (mg/dl), HDL cholesterol (mg/dl), LDL cholesterol (mg/dl), urea (mg/dl), creatinine (mg/dl), uric acid (mg/dl), complete blood count (hemogram), aspartate aminotransferase (AST) (IU/L), alanine aminotransferase (ALT) (IU/L) values will be checked at Erciyes University Central Laboratory.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group receiving nutritional intervention

The ideal food pyramid created for rheumatoid arthritis patients was applied to the patients and followed for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

The Ideal Food Pyramid, which has not been applied before, is used to observe disease activities and especially changes in intestinal microbiota in rheumatoid arthritis.

control group

Patients diagnosed with rheumatoid arthritis and meeting the inclusion criteria were included in the control group and no intervention was applied. At the beginning and end of the study, a questionnaire, blood and stool samples were taken.

Group Type: PLACEBO_COMPARATOR

Control (Standard treatment)

Intervention Type: OTHER

We chose a control group to show the effect of the intervention we would apply to the diet group and did not apply any intervention to the control group.

Interventions

Diet

The Ideal Food Pyramid, which has not been applied before, is used to observe disease activities and especially changes in intestinal microbiota in rheumatoid arthritis.

Intervention Type: OTHER

Control (Standard treatment)

We chose a control group to show the effect of the intervention we would apply to the diet group and did not apply any intervention to the control group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with Rheumatoid Arthritis by a rheumatologist and starting disease-modifying antirheumatic drug (DMARD) treatment.

2. Those with rheumatoid arthritis disease duration longer than 1 year

3. Being between the ages of 18-65

4. Body Mass Index (BMI)=18.5-40 kg/m2

5. Smoking three or less cigarettes per day

Exclusion Criteria

1. Those with cancer, diabetes, kidney, inflammatory bowel disease, and liver disease, psychiatric disorders

2. Those who use regular Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), those whose oral cortisol intake is >12.5 mg

3. Those who have used a special diet, herbal supplements, vitamin-mineral supplements (except for vitamin D), and probiotics in the last 3 months

4. Those who have received antibiotic treatment in the last 3 months

5. Those who are breastfeeding or pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Betül Cicek

Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ülger Kaçar Mutlutürk

Role: PRINCIPAL_INVESTIGATOR

Erciyes University Medical Faculty Hospital

Locations

Erciyes University Medical Faculty Hospital

Kayseri, Melikgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EU-BVD-UKM-02

Identifier Type: -

Identifier Source: org_study_id