Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, dietary fiber, mechanism
Brief summary
The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are: * To verify the effect of dietary fiber supplementation on reducing the level of inflammation; * To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis. The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made
Detailed description
Rheumatic arthritis (RA) is caused by chronic inflammation and joint injury caused by imbalance of pro-and anti-inflammatory mediators in the joints. Studies have shown that dietary fiber (DF) can be fermented by gut bacteria into anti-inflammatory short-chain fatty acid that may reduce joint inflammation, relieve symptoms and improve quality of life. The subjects were Randomized controlled trial to supplement DF12W individually, the intervention group to supplement DF12W, and the control group to supplement DF12W with routine diet, the differences of disease activity (DAS28 score) , inflammatory markers (TNF-a, IL-6, Mir-146a, Treg, ESR, CRP, etc.) and quality of life (SF-36) between the two groups were compared. The changes of intestinal flora were examined to verify the hypothesis. This study laid a good scientific foundation for dietary recommendation of RA patients.
Interventions
DIETARY_SUPPLEMENTOat bran (dietary fiber)
Dietary fiber, known as the seventh type of nutrients, refers to carbohydrate polymers that have health benefits for the human body, mainly derived from plant cell walls such as grains, fruits, and vegetables.Mediterranean cuisine is a dietary pattern
Sponsors
Shenzhen People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Researchers set blinding to reduce implementation bias
Intervention model description
Experimental group=1,Control Group=2,
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria, with a course of ≥ 2 years, and no changes in anti rheumatic drugs within 8 weeks prior to intervention; * Age: 18-75 years old; * DAS28-ESR ≥ 2.6 points, and fully controlled and treated with medication during screening visits; * Sign an informed consent form and be able to complete the experiment according to the protocol.
Exclusion criteria
* Patients with mental illness, cognitive impairment, severe heart, lung, brain failure, serious complications, pregnancy, or life-threatening diseases; * Patients with severe visual or auditory impairment and inability to understand research information; * During the past 8 weeks of treatment with disease modifying anti rheumatic drugs (DMARDs), patients with food intolerance, allergies, and unwillingness to consume the intervention food in the study; * In the past 10 years, there has been a history of tumors and eating disorders (such as neurogluttony, anorexia, binge eating, etc.); * Participated in other intervention studies in the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity score | 12 weeks | Questionnaire evaluation,Higher scores mean worse results |
| Quality of life score | 12 weeks | Health Assessment Questionnaire,Higher scores mean worse results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory indicators:IL-6 | 12 weeks | Inflammatory factors were detected by ELISA ,In pg/ml. |
| Inflammatory indicators :IL-10 | 12 weeks | Inflammatory factors were detected by ELISA ,In pg/ml. |
| Inflammatory indicators: ESR | 12 weeks | Inflammatory factors were detected by Weiss method,In mm/h. |
| Compliance of oat bran | 12 weeks | Use the follow-up record table to record the patients were followed up weekly on how many packets they ate . One pack a day, up to 7 packs a week, the greater the number, the better the compliance |
| gut flora | 12 weeks | Metagenesis is used to detect intestinal flora, InTags Per Million |
| Adjustment of anti rheumatic drugs | Week 12 | The increment and decrement are unchanged.Incremental means going from not taking a synthetic anti-rheumatic drug to taking a synthetic anti-rheumatic drug, or increasing the dose of the original drug, or increasing the type of drug, or from the original traditional synthesis of disease-improving anti-rheumatic drugs adjusted for the biological synthesis of disease-improving anti-rheumatic drugs. A reduction in the dose of a synthetic anti-rheumatic drug is defined as a reduction in the dose of a synthetic anti-rheumatic drug from taking it to discontinuing it, or a reduction in the dose of the original drug, or from the original bio-synthesis to improve the condition of anti-rheumatic drugs adjusted to traditional synthesis to improve the condition of anti-rheumatic drugs |
| Inflammatory indicators :CRP | 12 weeks | Inflammatory factors were detected by One-way immunodiffusion assay,In mg/L |
| Inflammatory indicators :TNF- α | 12 weeks | Inflammatory factors were detected by ELISA ,In pg/ml. |
Countries
China
Outcome results
None listed