The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis

Effect of Ideal Food Pyramid on Gut Microbiota, Disease Activity, Body Composition and Biochemical Parameters in Rheumatoid Arthritis: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Other: Diet; Other: Control (Standard treatment)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey, 38039
      • Erciyes University Medical Faculty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 >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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group receiving nutritional intervention; The ideal food pyramid created for rheumatoid arthritis patients was applied to the patients and followed for 12 weeks.	Other: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiota	Pre- and post-study stool samples were collected from all participants. To ensure sample integrity, all collected samples were immediately stored at -80°C until further processing. The stages of microbiota analysis are listed below, respectively.; DNA isolation from stool samples:- DNA extraction from stool samples was performed using the Qiagen Power Soil DNA Extraction Kit (Qiagen, Hilden, Germany). Quantification of double-stranded DNA (dsDNA) was performed using the Qubit dsDNA HS Assay Kit and a Qubit 2.0 Fluorimeter (Thermo Fisher Scientific, Waltham, MA, USA).; Illumina miSeq 16S rRNA next-generation sequencing. Analysis features:V4 variable region PCR amplificationPaired-end sequencing of 2 x 250 bp amplicons.At least 50,000 reads per sample (>Q30 quality) Data on microbiota are given in order of taxonomic classification from phylum to genus level.	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C reactive protein (CRP) (mg/dL)	CRP was measured twice, at the beginning and at the end of the study, using the immunoturbidimetric method on the Cobos c701 (Roche Diagnostic- Basel, Switzerland) autoanalyzer.	12 week
Erythrocyte sedimentation rate (ESR) (mg/dL)	Sedimentation rate will be studied twice, at the beginning and at the end of the study, using a Vision C ESR autoanalyzer (Shenzhen, China).	12 week
Total cholesterol,(mg/dL)	Total cholesterol will be measured spectrophotometrically on a Cobos c701 (Roche Diagnostic-Basel, Switzerland) autoanalyzer at the beginning of the study and at the end of 12 weeks.	12 week
LDL cholesterol (mg/dL)	LDL cholesterol will be measured spectrophotometrically on a Cobos c701 (Roche Diagnostic-Basel, Switzerland) autoanalyzer at the beginning of the study and at the end of 12 weeks.	12 week
DAS28ESR	DAS28-ESR includes the number of tender and swollen joints in 28 joints, the patient's estimate of their general health on the VAS, and the ESR. • DAS28-ESR was calculated as 0.56 × √(Tender joint count) + 0.28 × √(Swollen joint count) + 0.7 × ln ESR + 0.014 × VAS-GH. The score ranges from 0 to 9.4; values exceeding 5.1 are indicative of active disease and scores <3.2 indicate an inactive, well-controlled disease state.	12 week
DAS28CRP	DAS28-CRP includes the number of tender and swollen joints in 28 joints, the patient's estimate of their general health on the VAS, and the CRP. • DAS28-CRP was calculated as 0.56 × √(Tender joint count) + 0.28 × √(Swollen joint count) + 0.36 × ln (CRP + 1) + 0.014 × VAS-GH + 0.96 The score ranges from 0 to 9.4; values exceeding 5.1 are indicative of active disease and scores <3.2 indicate an inactive, well-controlled disease state.	12 week
The Simple Disease Activity Index (SDAI)	SDAI is calculated as the numerical sum of tender and swollen joint patient global assessment, physician global assessment, and C-reactive protein (CRP) level (mg/dL), with scores ranging from 0 to 86; A score of ≤ 3.3 is defined as remission, >3.3 to ≤ 11 indicates low disease activity, >11 and ≤ 26 indicates moderate disease activity, and high disease activity is defined by scores >40.	12 week
The Health Assessment Questionnaire (HAQ)	HAQ consists of 20 questions in 8 categories. Questions are scored from 0 to 3, with higher scores indicating worse functioning. Joint pain was measured using a horizontal visual analog scale (VAS) ranging from 0 to 10; higher scores indicate greater pain.	12 week
The Rheumatoid Arthritis Quality of Life instrument (RAQoL)	RAQoL consists of 30 questions, and participants are asked to indicate whether each question applies to them. Scores range from 0 to 30, with higher scores indicating lower quality of life.	12 week
The 36-item Short Form Health Survey (SF-36)	SF-36 measures health-related quality of life using eight items: physical function, physical role difficulty, pain, general health perception, energy/vitality, social functioning, emotional role difficulty, and mental health. The SF-36 scales range from 0 to 100, with higher scores indicating better quality of life.	12 week
Body fat percentage	Body fat percentage is shown as a percentage (%). Measurement was made at the beginning and end of the study using a Tanita BC 418MA brand (bioelectrical impedance device [BIA]). For BIA measurement, individuals were asked not to do any heavy physical activity 24-48 hours before, not to consume alcohol 24 hours before, to come with at least 4 hours of fasting, not to consume too much liquid (water, tea, coffee) before the analysis (at least 4 hours) and not to carry any metal objects on them.	12 week
Body fat mass	Body fat mass is calculated in kilograms. Measurement was made at the beginning and end of the study using a Tanita BC 418MA brand (bioelectrical impedance device [BIA]). For BIA measurement, individuals were asked not to do any heavy physical activity 24-48 hours before, not to consume alcohol 24 hours before, to come with at least 4 hours of fasting, not to consume too much liquid (water, tea, coffee) before the analysis (at least 4 hours) and not to carry any metal objects on them.	12 week
Body mass index (BMI)	The formula "BMI=Weight (kg)/Height (m²)" was calculated.	12 week
Waist circumference (cm)	The person to be measured is standing on their right side and the lowest rib bone is found and marked. The hip bone protrusion (cristailiac) is found on the hip and marked. The circumference passing through the middle of the two marked points is measured with a non-stretchable tape measure.	12 week
Hip circumference(cm)	Hip circumference is measured with a non-stretchable tape measure at the widest part of the hip when viewed from the side while the individual is standing. It is written in centimeters.	12 week
Neck circumference (cm)	Neck circumference is measured with a tape measure passing from the point where the neck and shoulders meet, just below the larynx.	12 week
Wrist circumference (cm)	Wrist circumference is measured with subjects in a seated position using a tension-gated tape measure placed over Lister's tubercle of the distal radius and the distal ulna.	12 week
Hand grip strength (kg)	The Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and accepted as the gold standard for many studies with high validity and reliability, was used to measure hand grip strength. During the test, they were informed not to hold their breath and not to shake the dynamometer. In order to determine the dominant hand, participants were asked which hand they used while eating or writing. Each hand was measured 3 times and the average was taken, with the patients in a sitting position, shoulder adduction and neutral rotation, elbow 90 degrees flexed, forearm in midrotation and supported wrist in neutral.	12 week

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Ülger Kaçar Mutlutürk, Erciyes University Medical Faculty Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Gut Microbiota; Ideal food pyramid
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: EU-BVD-UKM-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No