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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06322784
• Other study ID #: LiJingjing
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 10, 2024

Study information

• Verified date: March 2024
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 10, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

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

Locations

Country	Name	City	State
China	Jingjing Li	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View Citation

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(1 — View Citation

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;2017:48 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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 Oc — View Citation

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

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, Lu — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity score	Questionnaire evaluation,Higher scores mean worse results	12 weeks
Primary	Quality of life score	Health Assessment Questionnaire,Higher scores mean worse results	12 weeks
Secondary	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	12 weeks
Secondary	Inflammatory indicators :TNF- a	Inflammatory factors were detected by ELISA ,In pg/ml.	12 weeks
Secondary	Inflammatory indicators:IL-6	Inflammatory factors were detected by ELISA ,In pg/ml.	12 weeks
Secondary	Inflammatory indicators :IL-10	Inflammatory factors were detected by ELISA ,In pg/ml.	12 weeks
Secondary	Inflammatory indicators: ESR	Inflammatory factors were detected by Weiss method,In mm/h.	12 weeks
Secondary	Inflammatory indicators :CRP	Inflammatory factors were detected by One-way immunodiffusion assay,In mg/L	12 weeks
Secondary	gut flora	Metagenesis is used to detect intestinal flora, InTags Per Million	12 weeks
Secondary	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	Week 12