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

March 20, 2024 updated by: Shenzhen People's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Jingjing Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
12 week Mediterranean diet+dietary fiber intervention
Dietary supplement: Oat 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
Other Names:
  • The mediterranean Diet
No Intervention: Control group
12 week Mediterranean diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity score
Time Frame: 12 weeks
Questionnaire evaluation,Higher scores mean worse results
12 weeks
Quality of life score
Time Frame: 12 weeks
Health Assessment Questionnaire,Higher scores mean worse results
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
Inflammatory indicators :TNF- α
Time Frame: 12 weeks
Inflammatory factors were detected by ELISA ,In pg/ml.
12 weeks
Inflammatory indicators:IL-6
Time Frame: 12 weeks
Inflammatory factors were detected by ELISA ,In pg/ml.
12 weeks
Inflammatory indicators :IL-10
Time Frame: 12 weeks
Inflammatory factors were detected by ELISA ,In pg/ml.
12 weeks
Inflammatory indicators: ESR
Time Frame: 12 weeks
Inflammatory factors were detected by Weiss method,In mm/h.
12 weeks
Inflammatory indicators :CRP
Time Frame: 12 weeks
Inflammatory factors were detected by One-way immunodiffusion assay,In mg/L
12 weeks
gut flora
Time Frame: 12 weeks
Metagenesis is used to detect intestinal flora, InTags Per Million
12 weeks
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Investigators

  • Study Chair: Jingjing Li, Master, ShenZhen People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiJingjing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All ipds collected, all ipds behind published results

IPD Sharing Time Frame

  • After the paper was published
  • Always

IPD Sharing Access Criteria

Need researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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