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Rheumatoid Arthritis (RA)NCT06621927

The Effect of the Ideal Food Pyramid on Rheumatoid Arthritis

A study testing Diet in people with Rheumatoid Arthritis (RA), run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
Diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jun 2023to 20 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University Medical Faculty Hospital

    Kayseri, Melikgazi, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: 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.
Read more

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

Read the 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.

Being tested
Diet, Control (Standard treatment)
Keywords
Gut Microbiota, Ideal food pyramid, rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DietOther

    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 (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.

Study groups in NCT06621927
Study groupRoleWhat they receive
Group receiving nutritional interventionActive comparatorThe ideal food pyramid created for rheumatoid arthritis patients was applied to the patients and followed for 12 weeks.
Receives: Other: Diet
control groupPlacebo comparatorPatients 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.
Receives: Other: Control (Standard treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).
    1. 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.

    Measured: 12 week

Secondary outcomes (18)
  1. 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.

    Measured: 12 week

  2. 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).

    Measured: 12 week

  3. 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.

    Measured: 12 week

  4. 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.

    Measured: 12 week

  5. 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.

    Measured: 12 week

  6. 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.

    Measured: 12 week

  7. 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.

    Measured: 12 week

  8. 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.

    Measured: 12 week

  9. 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.

    Measured: 12 week

  10. 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.

    Measured: 12 week

  11. 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.

    Measured: 12 week

  12. 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.

    Measured: 12 week

  13. Body mass index (BMI)

    The formula "BMI=Weight (kg)/Height (m²)" was calculated.

    Measured: 12 week

  14. 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.

    Measured: 12 week

  15. 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.

    Measured: 12 week

  16. 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.

    Measured: 12 week

  17. 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.

    Measured: 12 week

  18. 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.

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start20 Jun 2023
  3. Primary completion20 Apr 2024
  4. Study completion20 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
two separate groups simultaneously diet and control
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621927
Sponsor's protocol ID
EU-BVD-UKM-02
Status last verified
Sep 2024
First submitted
18 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diet in people with Rheumatoid Arthritis (RA), run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut Microbiota (time frame: 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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