Clinical trial NCT06621927: The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis
Official title: Effect of Ideal Food Pyramid on Gut Microbiota, Disease Activity, Body Composition and Biochemical Parameters in Rheumatoid Arthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Keywords: Gut Microbiota
Ideal food pyramid
rheumatoid arthritis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two separate groups simultaneously diet and control
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion 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:

* 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 \&gt;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

Primary outcomes:
measure: Gut Microbiota
timeFrame: 12 week
Secondary outcomes:
measure: C reactive protein (CRP) (mg/dL)
timeFrame: 12 week
measure: Erythrocyte sedimentation rate (ESR) (mg/dL)
timeFrame: 12 week
measure: Total cholesterol,(mg/dL)
timeFrame: 12 week
measure: LDL cholesterol (mg/dL)
timeFrame: 12 week
measure: DAS28ESR
timeFrame: 12 week
measure: DAS28CRP
timeFrame: 12 week
measure: The Simple Disease Activity Index (SDAI)
timeFrame: 12 week
measure: The Health Assessment Questionnaire (HAQ)
timeFrame: 12 week
measure: The Rheumatoid Arthritis Quality of Life instrument (RAQoL)
timeFrame: 12 week
measure: The 36-item Short Form Health Survey (SF-36)
timeFrame: 12 week
measure: Body fat percentage
timeFrame: 12 week
measure: Body fat mass
timeFrame: 12 week
measure: Body mass index (BMI)
timeFrame: 12 week
measure: Waist circumference (cm)
timeFrame: 12 week
measure: Hip circumference(cm)
timeFrame: 12 week
measure: Neck circumference (cm)
timeFrame: 12 week
measure: Wrist circumference (cm)
timeFrame: 12 week
measure: Hand grip strength (kg)
timeFrame: 12 week
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty Hospital
state: Melikgazi
Study officials:
affiliation: Erciyes University Medical Faculty Hospital
name: Ülger Kaçar Mutlutürk
role: PRINCIPAL_INVESTIGATOR
References: