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).
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
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.
- Conditions
- Rheumatoid Arthritis (RA)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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)
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
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
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
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
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
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
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
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
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
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
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
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
Body mass index (BMI)
The formula "BMI=Weight (kg)/Height (m²)" was calculated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 Jun 2023
- Primary completion20 Apr 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Cicek, TC Erciyes University
- Investigators
- Ülger Kaçar Mutlutürk, Principal investigator, Erciyes University Medical Faculty Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ideal Food Pyramid on Gut Microbiota, Disease Activity, Body Composition and Biochemical Parameters in Rheumatoid Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06621927
- Acronym / sponsor ID
- EU-BVD-UKM-02
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Gut Microbiota, Ideal food pyramid, rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two separate groups simultaneously diet and control
| Arm | Type | Receives |
|---|---|---|
| Group receiving nutritional intervention | Active comparator | Other: DietThe ideal food pyramid created for rheumatoid arthritis patients was applied to the patients and followed for 12 weeks. |
| control group | Placebo comparator | Other: Control (Standard treatment)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietThe Ideal Food Pyramid, which has not been applied before, is used to observe disease activities and especially changes in intestinal microbiota in rheumatoid arthritis. | Other | Group receiving nutritional intervention |
| 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. | Other | control group |
Primary outcome
Gut Microbiota
Time frame: 12 week
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.
18 secondary outcomes
C reactive protein (CRP) (mg/dL)
Time frame: 12 week
Erythrocyte sedimentation rate (ESR) (mg/dL)
Time frame: 12 week
Total cholesterol,(mg/dL)
Time frame: 12 week
LDL cholesterol (mg/dL)
Time frame: 12 week
DAS28ESR
Time frame: 12 week
DAS28CRP
Time frame: 12 week
The Simple Disease Activity Index (SDAI)
Time frame: 12 week
The Health Assessment Questionnaire (HAQ)
Time frame: 12 week
The Rheumatoid Arthritis Quality of Life instrument (RAQoL)
Time frame: 12 week
The 36-item Short Form Health Survey (SF-36)
Time frame: 12 week
Body fat percentage
Time frame: 12 week
Body fat mass
Time frame: 12 week
Body mass index (BMI)
Time frame: 12 week
Waist circumference (cm)
Time frame: 12 week
Hip circumference(cm)
Time frame: 12 week
Neck circumference (cm)
Time frame: 12 week
Wrist circumference (cm)
Time frame: 12 week
Hand grip strength (kg)
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ülger Kaçar Mutlutürk principal investigator
Erciyes University Medical Faculty Hospital
1 site in 1 country: see every site and its status.
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.