Effect of Ideal Food Pyramid on Gut Microbiota, Disease Activity, Body Composition and Biochemical Parameters in Rheumatoid Arthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gut Microbiota
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Gut Microbiota
时间窗: 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.
次要结局
- Erythrocyte sedimentation rate (ESR) (mg/dL)(12 week)
- C reactive protein (CRP) (mg/dL)(12 week)
- Total cholesterol,(mg/dL)(12 week)
- LDL cholesterol (mg/dL)(12 week)
- DAS28ESR(12 week)
- DAS28CRP(12 week)
- The Simple Disease Activity Index (SDAI)(12 week)
- The Health Assessment Questionnaire (HAQ)(12 week)
- The Rheumatoid Arthritis Quality of Life instrument (RAQoL)(12 week)
- The 36-item Short Form Health Survey (SF-36)(12 week)
- Body fat percentage(12 week)
- Waist circumference (cm)(12 week)
- Body fat mass(12 week)
- Body mass index (BMI)(12 week)
- Hip circumference(cm)(12 week)
- Neck circumference (cm)(12 week)
- Wrist circumference (cm)(12 week)
- Hand grip strength (kg)(12 week)
研究者
Betül Cicek
Prof.Dr.
TC Erciyes University