Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322784
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-03-06
Brief Title:
DFOat Bran Intervention on Inflammation Intestinal Flora Disease Activity and Quality of Life in Patients With RA
Sponsor:
Shenzhen Peoples Hospital
Organization:
Shenzhen Peoples Hospital
Study Overview
Official Title:
Effects of Dietary Fiber Oat Bran Intervention on Inflammation Intestinal Flora Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None