NCT06322784Completed
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 6 Mar 2024
- Start date
- 1 Nov 2022
- Primary completion date
- 1 Dec 2022
- Lead sponsor
- Shenzhen People's Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06322784
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 1 Nov 2022 to the primary completion date, 1 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- In the past 10 years, there has been a history of tumors and eating disorders (such as neurogluttony, anorexia, binge eating, etc.);
Other
- Participated in other intervention studies in the past three months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jingjing Li Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.