AzTrials
AzTrials

Rheumatoid ArthritisNCT06322784

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

A study testing Oat bran (dietary fiber) in people with Rheumatoid Arthritis, run by Shenzhen People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Oat bran (dietary fiber)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Nov 2022to 10 Feb 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jingjing Li

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Oat bran (dietary fiber)
Keywords
Rheumatoid arthritis, dietary fiber, mechanism
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oat bran (dietary fiber)Dietary supplement

    Also called The mediterranean Diet

    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

Study groups in NCT06322784
Study groupRoleWhat they receive
Experimental groupExperimental12 week Mediterranean diet+dietary fiber intervention
Receives: Dietary Supplement: Oat bran (dietary fiber)
Control groupNo intervention12 week Mediterranean diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease activity score

    Questionnaire evaluation,Higher scores mean worse results

    Measured: 12 weeks

  2. Quality of life score

    Health Assessment Questionnaire,Higher scores mean worse results

    Measured: 12 weeks

Secondary outcomes (8)

  1. Compliance of oat bran

    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

    Measured: 12 weeks

  2. Inflammatory indicators :TNF- α

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

    Measured: 12 weeks

  3. Inflammatory indicators:IL-6

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

    Measured: 12 weeks

  4. Inflammatory indicators :IL-10

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

    Measured: 12 weeks

  5. Inflammatory indicators: ESR

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

    Measured: 12 weeks

  6. Inflammatory indicators :CRP

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

    Measured: 12 weeks

  7. gut flora

    Metagenesis is used to detect intestinal flora, InTags Per Million

    Measured: 12 weeks

  8. Adjustment of anti rheumatic drugs

    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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start1 Nov 2022
  3. Primary completion1 Dec 2022
  4. Study completion10 Feb 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental group=1,Control Group=2,
Masking
Single blind
Who is masked
Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322784
Sponsor's protocol ID
LiJingjing
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Durholz K, Hofmann J, Iljazovic A, Hager J, Lucas S, Sarter K, Strowig T, Bang H, Rech J, Schett G, Zaiss MM. Dietary Short-Term Fiber Interventions in Arthritis Patients Increase Systemic SCFA Levels and Regulate Inflammation. Nutrients. 2020 Oct 20;12(10):3207. doi: 10.3390/nu12103207.

    PubMed 33092271

  • Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int. 2014;2014:698313. doi: 10.1155/2014/698313. Epub 2014 Jan 12.

    PubMed 24524085

  • Troeng T. [Medical decisions--theories for practical use?]. Lakartidningen. 1988 Sep 21;85(38):3081. No abstract available. Swedish.

    PubMed 3199948

  • Pauley KM, Satoh M, Chan AL, Bubb MR, Reeves WH, Chan EK. Upregulated miR-146a expression in peripheral blood mononuclear cells from rheumatoid arthritis patients. Arthritis Res Ther. 2008;10(4):R101. doi: 10.1186/ar2493. Epub 2008 Aug 29.

    PubMed 18759964

  • Bergot AS, Giri R, Thomas R. The microbiome and rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2019 Dec;33(6):101497. doi: 10.1016/j.berh.2020.101497. Epub 2020 Mar 19.

    PubMed 32199713

  • Horta-Baas G, Romero-Figueroa MDS, Montiel-Jarquin AJ, Pizano-Zarate ML, Garcia-Mena J, Ramirez-Duran N. Intestinal Dysbiosis and Rheumatoid Arthritis: A Link between Gut Microbiota and the Pathogenesis of Rheumatoid Arthritis. J Immunol Res. 2017;2017:4835189. doi: 10.1155/2017/4835189. Epub 2017 Aug 30.

    PubMed 28948174

  • Liu X, Zou Q, Zeng B, Fang Y, Wei H. Analysis of fecal Lactobacillus community structure in patients with early rheumatoid arthritis. Curr Microbiol. 2013 Aug;67(2):170-6. doi: 10.1007/s00284-013-0338-1. Epub 2013 Mar 13.

    PubMed 23483307

  • Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.

    PubMed 26214836

  • Liu X, Zeng B, Zhang J, Li W, Mou F, Wang H, Zou Q, Zhong B, Wu L, Wei H, Fang Y. Role of the Gut Microbiome in Modulating Arthritis Progression in Mice. Sci Rep. 2016 Aug 2;6:30594. doi: 10.1038/srep30594.

    PubMed 27481047

  • Skoldstam L, Hagfors L, Johansson G. An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. Ann Rheum Dis. 2003 Mar;62(3):208-14. doi: 10.1136/ard.62.3.208.

    PubMed 12594104

  • Turesson Wadell A, Barebring L, Hulander E, Gjertsson I, Hagberg L, Lindqvist HM, Winkvist A. Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis). PLoS One. 2021 Oct 14;16(10):e0258716. doi: 10.1371/journal.pone.0258716. eCollection 2021.

    PubMed 34648598

  • Davis C, Bryan J, Hodgson J, Murphy K. Definition of the Mediterranean Diet; a Literature Review. Nutrients. 2015 Nov 5;7(11):9139-53. doi: 10.3390/nu7115459.

    PubMed 26556369

Questions about this trial

What is this clinical trial studying?

A study testing Oat bran (dietary fiber) in people with Rheumatoid Arthritis, run by Shenzhen People's Hospital at 1 site in China.

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 4 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 3 Sep 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 China. 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. 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?

Disease activity score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322784, which also lists 12 linked publications.

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 3 Sep 2024.

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