The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis

NCT06621927 | Completed

• 1 other identifier: EU-BVD-UKM-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis (RA)

Keywords

Gut Microbiota; Ideal food pyramid; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• 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. 1. 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). 2. Illumina miSeq 16S rRNA next-generation sequencing. Analysis features: * V4 variable region PCR amplification * Paired-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 Outcomes (18)

• C reactive protein (CRP) (mg/dL)

  12 week

• Erythrocyte sedimentation rate (ESR) (mg/dL)

  12 week

• Total cholesterol,(mg/dL)

  12 week

• LDL cholesterol (mg/dL)

  12 week

• DAS28ESR

  12 week

Study Arms (2)

Group receiving nutritional intervention

ACTIVE COMPARATOR

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

Other: Diet

control group

PLACEBO COMPARATOR

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)

Interventions

Diet 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.

Group receiving nutritional intervention

Control (Standard treatment) 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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Rheumatoid Arthritis by a rheumatologist and starting disease-modifying antirheumatic drug (DMARD) treatment.
• Those with rheumatoid arthritis disease duration longer than 1 year
• Being between the ages of 18-65
• Body Mass Index (BMI)=18.5-40 kg/m2
• Smoking three or less cigarettes per day

You may not qualify if:

• Those with cancer, diabetes, kidney, inflammatory bowel disease, and liver disease, psychiatric disorders
• Those who use regular Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), those whose oral cortisol intake is \>12.5 mg
• Those who have used a special diet, herbal supplements, vitamin-mineral supplements (except for vitamin D), and probiotics in the last 3 months
• Those who have received antibiotic treatment in the last 3 months
• Those who are breastfeeding or pregnant

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Medical Faculty Hospital

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ülger Kaçar Mutlutürk

  Erciyes University Medical Faculty Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: two separate groups simultaneously diet and control

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 1, 2024
• Study Start: June 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: June 20, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)