NCT06322784

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-01
• Primary completion: 2022-12-01
• Completion: 2024-02-10
• First posted: 2024-03-21
• Last updated: 2024-09-03

Locations

1 site across 1 country: China