Skip to main content
OpenTrials
Completed

NCT Number: NCT06322784

DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jingjing Li

Shenzhen, Guangdong, 518000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oat bran (dietary fiber)

Dietary Supplement

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

Other names: The mediterranean Diet

Primary outcomes

  1. Disease activity score

    Time frame: 12 weeks

    Questionnaire evaluation,Higher scores mean worse results

  2. Quality of life score

    Time frame: 12 weeks

    Health Assessment Questionnaire,Higher scores mean worse results

Secondary outcomes

  1. Compliance of oat bran

    Time frame: 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

  2. Inflammatory indicators :TNF- α

    Time frame: 12 weeks

    Inflammatory factors were detected by ELISA ,In pg/ml.

  3. Inflammatory indicators:IL-6

    Time frame: 12 weeks

    Inflammatory factors were detected by ELISA ,In pg/ml.

  4. Inflammatory indicators :IL-10

    Time frame: 12 weeks

    Inflammatory factors were detected by ELISA ,In pg/ml.

  5. Inflammatory indicators: ESR

    Time frame: 12 weeks

    Inflammatory factors were detected by Weiss method,In mm/h.

  6. Inflammatory indicators :CRP

    Time frame: 12 weeks

    Inflammatory factors were detected by One-way immunodiffusion assay,In mg/L

  7. gut flora

    Time frame: 12 weeks

    Metagenesis is used to detect intestinal flora, InTags Per Million

  8. Adjustment of anti rheumatic drugs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

Effects of Dietary Fiber (Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Mar 21, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.