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

NCT06322784 | Completed DMC

• 1 other identifier: LiJingjing
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; dietary fiber; mechanism

Outcome Measures

Primary Outcomes (2)

• Disease activity score

  Questionnaire evaluation,Higher scores mean worse results

  12 weeks

• Quality of life score

  Health Assessment Questionnaire,Higher scores mean worse results

  12 weeks

Secondary Outcomes (8)

• Compliance of oat bran

  12 weeks

• Inflammatory indicators :TNF- α

  12 weeks

• Inflammatory indicators:IL-6

  12 weeks

• Inflammatory indicators :IL-10

  12 weeks

• Inflammatory indicators: ESR

  12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

12 week Mediterranean diet+dietary fiber intervention

Dietary Supplement: Oat bran (dietary fiber)

Control group

NO INTERVENTION

12 week Mediterranean diet

Interventions

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

Also known as: The mediterranean Diet

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Jingjing Li

Shenzhen, Guangdong, 518000, China

Location

Related Publications (12)

• 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.

  PMID: 33092271 RESULT

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

  PMID: 24524085 RESULT

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

  PMID: 3199948 RESULT

• 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.

  PMID: 18759964 RESULT

• 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.

  PMID: 32199713 RESULT

• 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.

  PMID: 28948174 RESULT

• 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.

  PMID: 23483307 RESULT

• 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.

  PMID: 26214836 RESULT

• 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.

  PMID: 27481047 RESULT

• 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.

  PMID: 12594104 RESULT

• 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.

  PMID: 34648598 RESULT

• 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.

  PMID: 26556369 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jingjing Li, Master

  Shenzhen People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Researchers set blinding to reduce implementation bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group=1,Control Group=2,

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 21, 2024
• Study Start: November 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 10, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)