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NCT06621927Completed

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
18 Sept 2024
Start date
20 Jun 2023
Primary completion date
20 Apr 2024
Lead sponsor
TC Erciyes University
NCT number
NCT06621927

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 20 Jun 2023 to the primary completion date, 20 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Exclusion criteria
    • 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

Who the study is looking for

  • Inclusion criteria,
    • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Erciyes University Medical Faculty Hospital
Coordinator of this site? Confirm its status
KayseriTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.